Laboratorio Clinico Baco Statlab Ii

Summary Statement of Deficiencies D0000 An offsite Proficiency Test (PT) Desk Review was performed on October 16, 2025 to Laboratorio Clinico Bac Stat Lab II, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1403 Laboratory Director, Moderate 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 the Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025), the laboratory failed to achieve satisfactory performance ( 80% or 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 -- better ) for two (2) out of two (2) consecutive testing events for the specialty of hematology. Refer 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 the CASPER Report 0155D and PRPTSP scores (year 2025), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of two (2) consecutive testing events in a Proficiency Testing (PT) program approved by HHS, for the specialty of hematology. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on September 30, 2025, confirmed that the laboratory had a PT failures for specialty of hematology. The laboratory obtained the following testing scores: Specialty: Hematology a. First testing event year 2025 - 0% b. Second testing event year 2025 - 37% 2. A review of the PRPTSP records confirmed the above findings. 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 review of the CASPER Report 0155D and PRPTSP scores (year 2025), 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 D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 the CASPER Report 0155D and PRPTSP scores (year 2025), 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 D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program scores review ( 2023-2024 ) and laboratory director interview on October 25, 2024 at 9:00 A..M., it was determined that the laboratory failed to take and document

Summary Statement of Deficiencies D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, 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 serum Human Chorionic Gonadotropin (hCG) test quality control records (years 2021-2022) and interview with the laboratory general supervisor on November 23, 2022 at 10:45 a.m., it was determined that the laboratory failed to ensure compliance with the analytic system requirements for serum hCG qualitative tests. The finding includes: 1. The laboratory did not include each day of testing a negative and a positive control material when patients specimens were processed and reported for serum hCG qualitative test. Refer to D 5449 . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: 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 -- Based on hematology performance specifications records reviewed (1/10/2022 ) and laboratory general supervisor interview on November 23, 2022 at 10:09 a.m., it was determined that the laboratory failed to complete the evaluation of the performance specifications of the new hematology system. The findings include: 1. The laboratory acquired the system Mindray BC-5390 to perform (CBC) Complete Blood Count hematology tests on January 2022.(review on November 23, 2022 at 10:09 a.m. ) 2. The laboratory began to use the hematology system on January 10, 2022. (review on November 23, 2022 at 10:12 a.m. ) 3. From January 10, 2022 to November 23, 2022, the records showed that the laboratory did not verity the precision and manufacturer's reference intervals (normal values) appropriate for the laboratory's patient's sample prior to begin to test patient's samples.(review on November 23, 2022 at 10:15 a.m. ) 3. The laboratory general supervisor confirmed on November 23, 2022 at 10:30 a.m. that the data evaluation of precision and manufacturer's reference intervals (normal values) were not include in the system validation. 4. The laboratory processed and reported 1,782 hematology patient's samples (CBC) since January 2022. 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 endocrinology quality control records review ( year 2021-2022 ) and interview with the laboratory general supervisor on November 23, 2022 at 10:45 a.m. , it was determined that the laboratory failed to include a negative and positive control material when performed hCG test. The findings include : 1. The laboratory performed hCG ( human chorionic gonadotropin) by Alere one step method.( review on November 23, 2022 at 10:45 a.m. ) 2. Endocrinology quality control logs were reviewed from November 1, 2021 to November 23, 2022. ( review on November 23, 2022 at 10:50 a.m. ) 3. The records showed that the laboratory did not include a negative and positive control material from November 1, 2021 to October 31, 2022, when performed and reported 28 patient samples those days. ( review on November 23, 2022 at 10:50 a.m. ) 4. The laboratory general supervisor confirmed on November 23, 2022 at 10:55 a.m. , that the laboratory failed to include a negative and positive control material each day of testing when performed hCG test. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on hematology quality control records review in 2021-2022 and laboratory -- 2 of 4 -- general supervisor interview on November 23, 2022 at 9:30 AM, it was determined that the laboratory failed to evaluate and define twice a year the relationship between the manual cell differential and automatic cell differential. The findings include: 1. The laboratory performed automatic cell differential by Mindray hematology system. 2. Quality controls records were reviewed from February 19, 2021 to November 23, 2022. ( review on November 23, 2022 at 9:35 A.M. ) 3. The laboratory general supervisor confirmed on November 23, 2022 at 9:30 AM., that the laboratory failed to evaluate twice a year a relationship between the manual cell differential and automatic cell differential by hematology system since February 19, 2021. 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 hCG test quality control records ( year 2021-2022 ) and interview with the laboratory general supervisor on November 23, 2022 AM at 10:45 a.m., it was determined that the laboratory testing personnel failed to include a negative and positive control material when performed hCG test. The findings include: 1. The h CG quality control records showed that no positive neither negative control material were included each day of patient testing. Refer to D5449. 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 hCG test quality control records review ( year 2021-2022 ) laboratory supervisor interview on November 23, 2022 at 10:45 a.m., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D 6093 . 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 test quality control records ( year 2021-2022 ) and interview with the laboratory supervisor on November 23, 2022 AM at 10:45 a.m., it was determined that the laboratory director failed to ensure compliance with the requirements for analytic systems. The findings include: 1. The h CG quality control records showed -- 3 of 4 -- that no positive neither negative control material were included each day of patient testing. Refer to D5449. -- 4 of 4 --