Laboratorio Clinico Y Bacteriologico Santiago

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at LABORATORIO CLINICO Y BACTERIOLOGICO SANTIAGO on July 11, 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 July 11, 2024. 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: A. Based on human chorionic gonadotropin (hCG) quality control records review (years 2023-2024), patient's test worksheets records review and laboratory director interview on July 11, 2024 at 10:45 AM, it was determined that the laboratory failed to include an external negative and positive control material each day of testing when performed and reported 14 out of 32 hCG patient's samples from December 4,2023 to June 13,2024. The findings include : 1. The laboratory performed hCG patient's test by Alere one step method. (Reviewed on July 11, 2024 at 10:45 AM.) 2. The hCG quality control and patient's test worksheets records were reviewed from January 2023 to June 13, 2024. (Reviewed on July 11, 2024 at 10:50 AM.) 3. The hCG quality control record showed that the laboratory did not include an external negative and positive control material, each testing day, from December 4, 2023, to June 13, 2024. The laboratory only documented the internal procedure control with each patient. (Reviewed on July 11,2024 at 10:55 AM.) 4. The laboratory director confirmed on July 11, 2024 at 11:00 AM., that the laboratory failed to include a negative and 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 -- positive control material each day of testing when performed hCG test. B. Based on Mycoplasma pneumoniae IgM test quality control and patient test worksheet records review (year 2023-2024) and laboratory director interview on July 11, 2024 at 11:05 AM, it was determined that the laboratory failed to include an external negative and positive control material each day of Mycoplasma pneumoniae IgM patient testing, when 56 out of 99 patients were processed and reported from November 30, 2023 to April 29, 2024. The findings include: 1. The laboratory uses the Immunocard reagent kit to perform patient Mycoplasma pneumoniae IgM test. (Reviewed on July 11, 2024 at 11:05 AM.) 2. The Mycoplasma pneumoniae IgM quality control and patient's test worksheets reports were reviewed from November 30,2023 to July 9, 2024. (Reviewed on July 11, 2024 at 11:10 AM.) 3. The Mycoplasma pneumoniae IgM quality control and patient test worksheet records on July 11, 2024 at 11:10 AM, showed that the laboratory did not include any control material each day of patient testing from November 30, 2023 to April 29, 2024, when 56 out of 99 patients were processed and reported for Mycoplasma pneumoniae IgM testing. 4. The laboratory director confirmed on July 11, 2024 at 11:20 AM, that the laboratory failed to include a negative and positive control material each day of patient testing for Mycoplasma pneumoniae IgM. 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 hCG and Mycoplasma pneumoniae IgM test quality control, patient test worksheet records review and laboratory director interview on July 11, 2024 at 1:00 P. M., 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 hCG and Mycoplasma pneumonia IgM tests. Refer to D5449. -- 2 of 2 --

Summary Statement of Deficiencies 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 D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on hematology calibration verification records review ( 2017-2018 ), laboratory general supervisor and laboratory director interview on August 9, 2018 at 11:30 A.M., it was determined that the laboratory failed to perform the calibration verification procedures at least the frequency recommended by the manufacturer ( annually ) . The findings include : 1. The laboratory acquired in May 2017 a new Sysmex XS 1000i to perform hematology tests. 2. Review the hematology calibration verification records , showed that the laboratory did not perform the calibration verification procedures of the hematology system since May 9, 2017. 3. The laboratory general supervisor confirmed on August 9, 2018 at 11:3. A.M., that the laboratory did not perform the calibration verification procedures as least the frequency recommended by the manufacturer ( annually ) . 4. The laboratory performed and reported 9,239 hematology patient samples ( Complete blood cell count ) in 2017. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) 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 -- (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 hematology calibration verification records ( 2017-2018 ) and laboratory director interview on August 9, 2018 at 11:30 A.M., it was determined that the laboratory failed to ensure compliance with requirements for analytic systems. The findings include: 1. The laboratory did not perform the hematology calibration verification procedures as least the frequency recommended by the manufacturer ( annually ) . 2. The laboratory director confirmed on August 9, 2018, that the laboratory failed to ensure compliance with requirements for analytic systems. Refer to D5437. 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 hematology calibration verification records review ( 2017-2018) and laboratory director interview on August 9, 2018 at 11:30 A.M. , it was determined that the laboratory director failed to ensure compliance with the requirements for analytic system. Refer to D5437. 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 hematology calibration verification records and laboratory director interview on August 9, 2018 at 11:30 A.M., it was determined that the general supervisor failed to ensure compliance with the requirements for analytic system. The finding includes: 1. The laboratory general supervisor confirmed on August 9, 2018 at 11:30 A.M. ,that the laboratory failed to ensure compliance with the requirements for analytic system. Refer to D5437. -- 2 of 2 --