Lab Clinico Y Bacteriologico Santiago

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on June 30, 2026 to Laboratorio Clnico y Bacteriologa Santiago, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1441 Laboratory Director, High Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 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 -- 2025-2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of three (3) consecutive testing events for the specialty of hematology in the analyte for Hemoglobin (HGB) tests. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of three (3) consecutive testing events for the specialty of hematology in the analyte for Hemaglobin (HGB) tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on June 21, 2026, confirmed that the laboratory had a PT (Proficiency Test) failure for the analyte Hemoglobin (HGB) tests in the specialty of hematology. The laboratory obtained the following testing scores: Analyte: Hemoglobin (HGB) a. Second testing event year 2025 - 40% b. First testing event year 2026 - 0% 2. A review of the PRPTSP records confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on review of Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program ( PRPTP ) records review ( 2022- 2023 ) and laboratory general supervisor interview on December 12, 2023 at 9:00 A. M. , it was determined that the laboratory director and testing personnel failed to sign the attestation statements. The findings include: 1. Puerto Rico Proficiency testing records were review from February 2022 to November 2023. ( review at 9:05 A.M. ) 2. The review of records showed that the laboratory director and laboratory general supervisor ( testing personnel ) did not sign the attestation statements of the Proficiency testing records from February 2022 to November 2023. ( review at 9:05 a. m. ) 3. The laboratory general supervisor confirmed on December 12, 2023 at 9:10 A. M.that the laboratory director and general supervisor ( testing personnel ) failed to sign the attestation statements since 2022. 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 records reviewed ( 2022-2023) 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 -- and laboratory supervisor interview on December 12, 2023 at 9:17 A.M , it was determined that the laboratory failed to report the hematology proficiency testing results within the time frame established by the program. The findings include: 1. Puerto Rico Proficiency testing records were reviewed from February 2022 to November 2023. 2. The deadline of the second testing event report of hematology tests was June 23, 2023. 3. The laboratory did not report the second testing event of hematology within the time frame established by the Proficiency Testing Program and results in a score of 0 for the testing event. 4. The laboratory general supervisor confirmed on December 12, 2023 at 9:25 A.M., that the laboratory did not report the hematology proficiency testing results of the second testing event within the time frame established by the Proficiency Testing Program. 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 Pregnancy Combo test ( One step assay ) manufacturer's instruction review, hCG ( human chorionic hormone ) work sheets records and laboratory general supervisor interview on December 12, 2023 at 11:00 A.M .it was determined that the laboratory failed to follow manufacturer's instruction when report hCG results on January 31, 2023, October 27, 2023 and October 30, 2023. The findings include: 1. The Pregnancy Combo test ( One step assay ) manufacturer's instruction establish that the interpretation of the results must be as follow : positive : If both C line and T line appear, the test indicates that hCG is detected in the specimen. negative: If only the C line appears , the test indicates that the hCG level in the specimen is not detectable and the result is negative. 2. The hCG work sheets showed that the laboratory reported three hCG patients samples as borderline result the following days: January 31, 2023, October 27, 2023 and October 30, 2023. 3. The laboratory general supervisor confirmed on December 12, 2023 at 11:15 A.M. , that the laboratory failed to follow manufacturer's instruction when report hCG results those days. 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 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 lack of Mycoplasma Pneumoniae IgM test verification of new lot reactivity records , Mycoplasma Pneumoniae IgM quality control test records ( year 2022-2023) , and laboratory general supervisor interview on December 12, 2023 at 11:20 A.M, it -- 2 of 4 -- was determined that the laboratory did not evaluate the new lots of Mycoplasma Pneumoniae IgM test for positive and negative reactivity prior to placing it in routine use. The findings include: 1. On December 12, 2023 at 11: 20 A. M, the laboratory general supervisor stated that the laboratory performs Mycoplasma Pneumoniae IgM tests with the Immunocard test kit. 2. The Mycoplasma Pneumoniae IgM quality control test records were reviewed from Januay 2023 to November 30, 2023 and showed that the laboratory did not evaluate the new lots of Mycoplasma Pneumoniae IgM test for positive and negative reactivity prior to placing it in routine use. ( Reviewed on December 12, 2023 at 11:25 A.M ) 3. The laboratory general supervisor confirmed that the laboratory used the following lots of Mycoplasma pneumoniae and failed to perform the verification of the new lots for positive and negative reactivity prior to placing it in routine use. Lot number date opened patient testing 709030Q220 4/26/23 192 709030Q236 9/18/23 42 709030Q238 9/30/23 144 4. The laboratory general supervisdor confirmed on December 12, 2023 at 11:30 A.M. , that the laboratory did not evaluate the new lots of Mycoplasma Pneumoniae IgM tests for positive and negative reactivity prior to placing it in routine use. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Program testing records review ( 2022-2023 ) and laboratory general supervisor interview on December 12, 2023 at 9:00A.M., it was determined that the laboratory director failed to ensure that proficiency testing samples were tested as required under Subpart H requirements. Refer to D2009 and D2127. 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 endocrinology ( hCG) , Mycoplasm pneumoniae quality control record review from January 1, 2022 to December 12, 2023, 2019 and laboratory general supervisor interview on December 12, 2023 at 12:15 p.m. it was determined that the laboratory director failed to ensure compliance with the requirement for analytic systems. The findings include: 1. The laboratory failed to follow manufacturer's instruction when report hCG results. Refer to D5405. 2.The laboratory did not evaluate the new lots of Mycoplasma Pneumoniae IgM test for positive and negative reactivity prior to placing it in routine use. Refer to D5471. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the -- 3 of 4 -- laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on general immunology (Mycoplasma pneumoniae) quality control records review ,endocrinology ( hCG) manufacturer's instruction review from January 2022 to December 2023 and laboratory general supervisor interview on December 12, 2023 at 12:15 P.M. it was determined that the general supervisor failed to ensure compliance with the requirement for analytic systems. The finding includes: 1. The laboratory failed to follow manufacturer's instruction when report hCG results. Refer to D5405. 2. The laboratory did not evaluate the new lots of Mycoplasma Pneumoniae IgM test for positive and negative reactivity prior to placing it in routine use. Refer to D5471. -- 4 of 4 --