Laboratorio Clinico Bio Tech Ii

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Bio Tech II on May 20, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on May 20, 2026. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 direct observation of the laboratory refrigerator #2, lack of refrigerator #2 temperature records, manufacturer's instructions, and interview with the laboratory director on May 20, 2026 at 9:04 AM, the laboratory failed to monitor and document the refrigerator #2 temperature. The findings include: 1. On May 20, 2026 at 9:04 AM, direct observation of the laboratory refrigerator #2 showed that it was being used to store chemistry reagents. The refrigerator had the following reagents: 4 Triglycerides, 5 Urea, 4 HDL (High density lipoprotein), 2 Normal saline, 4 ALKP (Alkaline phosphatase), 5 Glucose, 5 Cholesterol, 4 AST (Aspartate aminotransferase), 5 ALT (Alanine aminotransferase), 3 Microalbumin, 1 BUN (Blood urea nitrogen), 1 Creatinine, 1 Human Assayed Multi-sera Level 2 control, 1 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 -- Human Assayed Multi-sera Level 3 control, 1 Liquid urine control level 2, 1 Liquid urine control level 3, 1 Direct LDL (Low density lipoprotein)/HDL (High density lipoprotein) Calibrator, and 1 Microalbumin Calibrator set. 2. On May 20, 2026 at 9: 10 AM, review of the manufacturer's instructions showed that all chemistry reagents stored in the refrigerator #2 temperature range must be between 2-8 C. 3. On May 20, 2026 at 9:15AM, the refrigerator #2 temperature records were requested. The laboratory director stated that refrigerator #2 was acquired on February 28, 2026, and that the laboratory did not document refrigerator #2 temperature records from February 28, 2026 to May 20, 2026, when they processed and reported 4,868 patient chemistry tests. 4. The laboratory director confirmed on May 20, 2026 at 9:20 AM, that the laboratory did not monitor and document the refrigerator #2 temperature, when they used the stored reagents to process and report 4,868 patient chemistry samples from February 28, 2026 to May 20, 2026. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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: Based on review of the chemistry Randox Imola instrument performance verification results, and laboratory director interview on May 20, 2026 at 10:49 AM, the laboratory failed to evaluate the instrument's performance verification obtained results. The findings include: 1. On May 20, 2026 at 10:49 AM, review of the chemistry Randox Imola instrument performance verification results did not reflect the evaluation and signature of the laboratory director prior to begin to test chemistry patient samples. 2. On May 20, 2026 at 10:52 AM, laboratory supervisor stated that the chemistry Randox Imola instrument was used to perform patient testing since December 1, 2025. 3. The laboratory director confirmed on May 20, 2026 at 10:59 AM that the laboratory director did not evaluate and sign the performance verification of the chemistry Randox Imola instrument. 4. The laboratory processed and reported 13,402 chemistry tests on the Randox Imola instrument from December 1, 2025 to May 20, 2026. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and 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 direct observation of the laboratory refrigerator #2, lack of refrigerator #2 temperature records, lack of evaluation of the chemistry instrument performance verification results, manufacturer's instructions, and interview with the laboratory -- 2 of 3 -- director on May 20, 2026 at 10:59 AM, the laboratory director failed to fulfill her responsabilities and duties to ensure compliance with the chemistry quality control requirements. Refer to D5413 and D5421. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) (b)(3) 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 direct observation of the laboratory refrigerator #2, lack of refrigerator #2 temperature records, manufacturer's instructions, and interview with the laboratory director on May 20, 2026 at 10:59 AM, the laboratory testing personnel failed to perform and document all quality control activities to ensure compliance with the chemistry quality control requirements. Refer to D5413 and D5421. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on May 14, 2026 to Laboratorio Clnico Bio Tech 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 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) 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 -- for two (2) out of two (2) consecutive testing events for the subspecialty of routine chemistry in the analyte Hemoglobin A1C (HA1C)) tests. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 two (2) consecutive testing events in the subspecialty of routine chemistry for the analyte Hemoglobiin A1C (HA1C) tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on May 10, 2026, confirmed that the laboratory had a PT (Proficiency Test) failure in the subspecialty of routine chemistry for the analyte Hemoglobiin A1C (HA1C) tests. The laboratory obtained the following testing scores: Analyte: Hemoglobiin A1C (HA1C) a. Third testing event year 2025 - 40% b. First testing event year 2026 - 60% 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 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 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 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 D2096. -- 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 Proficiency Testing program records review (year 2023) and laboratory director interview on May 7, 2024 at 9:14 AM; it was determined that the laboratory failed to attestated that the proficiency samples were tested in the same manner that they tested the laboratory patient samples. The findings include: 1. On May 7, 2024 at 9: 00 AM, the proficiency testing program record was reviewed. The proficiency attestation statement year 2023 were requested. The laboratory director did not provide any attestation statement of the year 2023. 2. The laboratory director stated, on May 7, 2024 at 9:14 AM, that they no print nor signed the attestation statement of the proficiency program for the year 2023. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; 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 -- This STANDARD is not met as evidenced by: Based on the review of the profiency program record and interview with the laboratory director on May 7, 2024 at 9:14 AM, it was determined that the laboratory director fail to meet the required requirements under subpart H. Refer to D2009. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 manufacturer's instructions, rapid plasma regain (RPR) test quality control records and laboratory director interview on June 15, 2018 at 11:00 AM, it was determined that the laboratory failed to follow manufacturer's instructions when 56 out of 56 patients specimens were tested and reported for RPR by Immnuno Detector RPR method from January 11, 2018 to June 14, 2018. The findings include: 1. The Immnuno Detector RPR manufacturer instructed the laboratory to perform the RPR tests at room temperature range from 23 to 29 C. 2. On June 15, 2018 at 11:00 AM, the RPR test quality control records showed that the laboratory tested and reported 56 out of 56 patients for RPR tests at temperatures below the manufacturer required from January 11, 2018 to June 14, 2018: Date temperature (C) January 11, 2018 22 January 16, 2018 22 January 22, 2018 21 January 24, 2018 22 January 30, 2018 22 February, 1, 2018 21 February, 5, 2018 22 February, 7, 2018 22 February, 8 2018 22 February, 12, 2018 22 February, 14, 2018 21 February, 15, 2018 22 February, 26, 2018 22 March 3, 2018 21 March 10, 2018 22 March 14, 2018 21 March 17, 2018 22 March 19, 2018 21 March 22, 2018 22 April 2, 2018 21 April 3, 2018 22 April 13, 2018 22 April 25, 2018 22 April 26, 2018 22 May 1, 2018 22 May 7, 2018 22 May 15, 2018 22 May 23, 2018 22 May 24, 2018 22 May 28, 2018 22 May 29, 2018 22 June 4, 2018 22 June 6, 2018 22 June 13, 2018 22 June 14, 2018 22 3. The laboratory director 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 -- confirmed on June 15, 2018 at 11:10 AM, that the laboratory tested and reported 56 out of 56 patients for RPR tests at temperatures below the manufacturer required from January 11, 2018 to June 14, 2018. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved