Laboratorio Clinico Frontera

Summary Statement of Deficiencies D0000 An offsite Proficiency Test (PT) Desk Review was performed on February 12, 2026 to Laboratorio Clinico Frontera, 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 (year 2025), the laboratory failed to achieve satisfactory performance (80% or better) for 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 -- two (2) out of three (3) consecutive testing events for the specialty of hematology in the analyte for Hematocrit (HCT) 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 (year 2025), 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 Hematocrit (HCT) tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on February 11, 2026, confirmed that the laboratory had a PT (Proficiency Test) failure for the analyte Hematocrit (HCT) tests in the specialty of hematology. The laboratory obtained the following testing scores: Analyte: Hematocrit (HCT) a. First testing event year 2025 - 60% b. Third testing event year 2025 - 20% 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 (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 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 (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 D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on facility records review (in years 2021-2022 ) and laboratory general supervisor interview at 9:00 AM on October 28, 2022, it was determined that the laboratory failed to be in compliance with the Puerto Rico State laboratory regulation. The findings include: 1. The laboratory Biomedical Generator Number ( DBR-RM-50- 14-02-0101 ) was due since October 23, 2022. 2. The laboratory general supervisor confirmed on October 28, 2022 at 9:00 A.M., that the laboratory not renew the new Biomedical Generator Number. 3. The state law establishes that the Biomedical Generator Number must be renew 60 days before the expired date. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on quality assessment procedure manual, quality assessment ( QA ) records review (year 2021-2022) and interview with the laboratory general supervisor interview on October 28, 2022, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following 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 -- requirements for preanalytic systems: patient test requests The findings include: 1. Review of the quality assessment program showed that evaluations to patient test request must be evaluated biannually. ( review on October 28, 2022 at 10:30 a.m. ) 2. Review of the quality assessment records showed that the last evaluation to patient test requests was performed in May 2021. ( review on October 28, 2022 at 10:30 a.m.) 3. The laboratory general supervisor confirmed that evaluations to test requests scheduled for performed biannually was not performed. ( review on October 28, 2022 at 10:35 a.m.) 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) procedure manual, QA assessment records review (year 2021-2022) and interview with the laboratory general supervisor interview on October 28, 2022, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following requirements for postanalytic systems: turn around time and the patient's final test reports. The findings include: 1. Review of the quality assessment program showed that evaluations related to the laboratory turn around time and the patient's final test reports. must be evaluated biannually. ( review on October 28, 2022 at 10:40 a.m.) 2. Review of the quality assessment record showed that the last turn around time and patient's final test reports evaluation was performed in June 2021. ( review on October 28, 2022 at 10:40 a.m. ) 3. The laboratory general supervisor confirmed on October 28, 2022 at 10:45 a.m. , that the laboratory failed to perform the evaluations of turn around time and the patient's final test reports. 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 ( year 2021-2022 ) and laboratory general supervisor interview on October 28, 2022 at 11:15 A.M., it was determined that laboratory failed to ensure compliance with quality assessment (QA) requirements. The findings include: 1. Quality Assessment records ( 2021-2022 ) showed that the laboratory did not evaluate the established Quality Assessment Program to monitor and evaluate the requirements for laboratory preanalytic and postanalytic systems. ( review on October 28, 2022 at 11:20 a.m. ) 2. The laboratory general supervisor confirmed on October 28, 2022 at 11: 25 a..m. , that failed to evaluate the requirements for laboratory preanalytic and postanalytic systems. Refer to D5391 and D5891. -- 2 of 2 --