Laboratorio Clinico Beatriz Inc

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 laboratory procedures manual, laboratory quality control records review and laboratory supervisor interview on January 18, 2024 at 11:13 AM, it was determined that the laboratory failed to monitor and document the laboratory's voltage, refrigerator and freezer temperatures and the preventive maintenance of the eye wash station. The findings include: 1. The laboratory procedures manual was reviewed on January 18, 2024 at 11:00 AM; and showed that the laboratory has established that the laboratory monitor and document the voltage, refrigerator and freezer temperature and the preventive maintenance of the eye wash station must be daily. 2. The quality control record showed that since December 2022, the laboratory did not monitor and document the daily the voltage, refrigerator and freezer temperatures and the preventive maintenance of the eye wash station. 4. The laboratory supervisor confirmed on January 18, 2024 at 11:13 AM, that the laboratory did not monitor and document the voltage, refrigerator and freezer temperatures, and the preventive maintenance of the eye wash station since December 2022. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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 -- For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on laboratory procedures manual, laboratory quality control records review and laboratory supervisor interview on January 18, 2024 at 11:13 AM, it was determined that the laboratory failed to monitor and document the laboratory maintenance of rotator, centrifuge maintenance, microscope maintenance since December 2022. The findings include: 1. The laboratory procedures manual was reviewed on January 18, 2024 at 11:00 AM; and established that the laboratory must monitor and document, every day, the rotator maintenance, centrifuge maintenance, microscope maintenance. 2. The quality control showed that since December 2022 the laboratory did not monitor and document the daily rotator maintenance, centrifuge maintenance, microscope maintenance. 4. The laboratory supervisor confirmed on January 18, 2024 at 11:13 AM, that the laboratory did not monitor and document the rotator maintenance, centrifuge maintenance and microscope maintenance since December 2022. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on hematology calibration records reviewed and laboratory supervisor interview on January 18, 2024 at 10:26 AM, it was determined that the laboratory failed to perform the calibration verification procedures with at least the frequency -- 2 of 4 -- recommended by the manufacturer's instructions (semi-annually) for the hematology tests performed by the Sysmex XN-350 hematology system. The laboratory did not performed the calibration verification procedures scheduled for December 2022, June 2023 neither December 2023. The findings include: 1. The laboratory uses a Sysmex XN-350 hematology system for CBC (Complete blood count) patient's tests. 2. The manufacturer's instructions establishes that the laboratory must perform the calibration verification procedures semi-annually. 3. On January 18, 2024 at 10:00 AM, the calibration records of XN-350 hematology system showed that the laboratory did not perform at least semi-annually the calibration verification procedures. The last calibration verification procedures were done on June 2022. 4. The laboratory supervisor confirmed on January 18, 2024 at 10:26 AM, that the laboratory did not perform at least semi-annually the calibration verification procedures for the XN-350 hematology system. The laboratory processed and reported 1,732 CBC patient's samples from June 2023 to December 2023. 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 (QA) records and laboratory supervisor interview on January 18, 2024 at 9:35 AM, it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirement for analytic systems. The findings include: 1. On January 18, 2024 at 9:30 AM, the laboratory QA record was requested and showed that the specimen and reagent storage conditions must be performed twice a year. 2. Since January 2023 the laboratory did not evaluate practices related to: specimen and reagent storage conditions. 3. The laboratory supervisor confirmed on January 18, 2024 at 9:35 AM, that the laboratory did not evaluate the specimen and reagent storage conditions since January 2023. 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 and laboratory supervisor interview on January 18, 2024 at 9:42 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following requirements for postanalytic systems: accuracy of calculated data and results sent to interfaced systems. The findings include: 1. The Quality Assessment records was reviewed on January 18, 2024 at 9:30AM, and showed that the evaluations of the laboratory calculated data for hematology and chemistry, and the results sent to interfaced systems must be performed twice a year. 2. The laboratory did not evaluate the accuracy of calculated data and the results sent to interfaced -- 3 of 4 -- system since December 2022. 3. The laboratory supervisor confirmed on January 18, 2024 at 9:42 AM, that the laboratory did not evaluate the accuracy of calculated data and the results sent to interfaced system since December 2022. 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 the quality control records review (year 2023 and 2024), and interview with the laboratory supervisor on January 18, 2024 at 11:30 AM; it was determined that the laboratory director failed to ensure that the quality control program were follow. Refer to D5413, D5435 and D5437. 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 Assesstment (QA) records reviewed and interview with the laboatory supervisor on January 18, 2024 at 11:30 AM; it was determined that the laboratory director failed to ensure the compliance with QA requirements year 2023. Refer to D5791 and D5891. -- 4 of 4 --

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) testing records review and interview with the laboratory supervisor on February 17, 2022 at 10:09 AM, it was determined that the laboratory did not include each day of testing an external positive and negative control material when 27 out of 27 patients specimens were tested and reported for of Mycoplasma pneumoniae patient testing from October 1, 2021 to October 27, 2021. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests. The record was reviewed from April 27, 2021 to December 30, 2021. 2. On February 17, 2022 at 10:00 AM, review of Mycoplasma pneumoniae testing record showed that the laboratory performs patient testing from October 1, 2021 to October 27, 2021. The laboratory did not include each day of testing the external control materials. 3. The laboratory supervisor confirmed on February 17, 2022 at 10:09 AM, that the laboratory failed to include each day of patient testing the external negative and positive control material . He stated that the laboratory run the external controls when it received a new reagent kit. 4. The laboratory processed and reported 27 patients specimens for Mycoplasma pneumoniae from October 1, 2021 to October 27, 2021. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(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 -- 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 Mycoplasma pneumonia IgM quality control records and interview with the laboratory supervisor on February 17, 2022 at 10:09 AM, it was determined that the laboratory director did not make sure to include a positive and a negative control material each day of patient testing for Mycoplasma pneumonia tests. Refer to D5449. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on syphillis serology records review in 2016-2018 and laboratory general supervisor interview at 10:00 AM on March 8, 2018, it was determined that the laboratory failed to perform syphillis serology test as required by manufacturer's instructions by TECO method. The findings include: 1. The laboratory syphillis serology quality control were review from March 2016 to March 7, 2018. 2. The manufacturer's requires that the laboratory must perform the needle calibration, verify the rotator rpm and monitor the room temperature in the laboratory. 3. From March 2016 to March 7, 2018, the records showed that the laboratory did not document nor verify the needle calibration in RPR (Rapid plasma reagin) testing area. 4. The laboratory processed and reported two hundred thirty (230) RPR (Rapid plasma reagin) patient's samples since March 2016. 5. The laboratory general supervisor confirmed on March 8, 2018 that the laboratory failed to document nor verify the needle calibration when processes RPR to ensure that the dropping bottle and needle dispense an appropriate amount of antigen needed to perform the test. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced 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 -- 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on virology quality control records review and laboratory general supervisor interview at 9:30 AM on March 8, 2018, it was determined that the laboratory did not evaluate the new lots of Influenza A-B test by Osom method for positive and negative reactivity prior to placed it in routine use. The findings include: 1. The laboratory uses Osom method for Influenza A-B patient's tests. 2. From March 2016 to March 2018, the records showed that the laboratory received and opened the following reagent kit for Influenza A-B and no evaluation of their reactivity was performed: Lot Expiration Date Opened 151468 2/2017 1/10/17 161439 3/31/18 2/14/17 161474 3/31/18 12/8/17 3. The laboratory processed and reported twenty one (21) Influenza A-B patient's samples since 2017. 4. The laboratory general supervisor confirmed on March 8, 2018, that the laboratory did not evaluate the new lots of Influenza A-B test by Osom method since 2017. 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 (QA) records review in 2016-2018 and laboratory general supervisor interview on March 8, 2018 at 10:30 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for analytic systems. The findings include: 1. The laboratory failed to perform syphillis serology test as required by manufacturer's instructions by TECO method. Refer to D5411. 2. The laboratory did not evaluate the new lots of Influenza A-B test by Osom method for positive and negative reactivity prior to placed it in routine use. Refer to D5471. 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 virology and syphillis serology quality control records review from March 2016 to March 2018 and laboratory general supervisor interview at 10:30 AM on March 8, 2018, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. Refer to D5411 and D5471. -- 2 of 3 -- 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 in 2016-2018 and laboratory general supervisor interview at 10:30 a.m. on March 8, 2018, it was determined that laboratory director failed to ensure compliance with quality assessment (QA) requirements. Refer to D5791. 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 quality control records review in 2016-2018 and laboratory general supervisor interview on March 8, 2018 at 10:30 AM, it was determined that the general supervisor failed to follow quality control procedures. The findings include: 1. The laboratory failed to perform syphillis serology test as required by manufacturer's instructions by TECO method. Refer to D5411. 2. The laboratory did not evaluate the new lots of Influenza A-B test by Osom method for positive and negative reactivity prior to placed it in routine use. Refer to D5471. -- 3 of 3 --