Lab Clinico Punta Santiago

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 3, 2026 to Laboratorio Clnico Punta Santiago, 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 (year 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 -- 2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of two (2) consecutive testing events for the subspecialty of routine chemistry in the analyte Total Protein 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 (year 2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of two (2) consecutive testing events for the subspecialty of routine chemistry in the analyte Total Protein tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on August 3, 2026, confirmed that the laboratory had a PT (Proficiency Test) failure for the analyte Total Protein tests in the subspecialty of routine chemistry. The laboratory obtained the following testing scores: Analyte: Total Protein a. First testing event year 2026 - 60% b. Second 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 (year 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 (year 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 D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Punta Santiago on March 19, 2025. 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 March 19, 2025. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: A. Based on hematology quality control records review and laboratory director interview on March 19, 2025 at 10:48 AM, it was determined that the laboratory failed to verify the stated value of the new lot of control materials, when the laboratory processed and reported 324 Complete Blood Count (CBC) patient samples from January 1, 2024 to March 5, 2024. The findings include: 1. The laboratory performs hematology CBC tests with the Beckman Coulter Ac.T 5 Diff CP system. 2. The hematology quality control records reviewed on March 19, 2025 at 10:48 AM, from January 1, 2024 to March 5, 2024, showed that there was no evaluation of the manufacturer's stated values for the lot numbers 380124 (high control level), 370124 (normal control level), and 360124 (low control level) prior to placing them in routine 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 -- use on January 1, 2024. 3. The laboratory director stated on March 19, 2025 at 10:48 AM, that no evaluations of the stated lots of control materials were performed prior to placing them in routine use. 4. The laboratory director confirmed on March 19, 2025 at 10:53 AM, that the laboratory failed to evaluate the stated value of the new lot of control materials for hematology CBC tests performed by the Beckman Coulter Ac.T 5 Diff CP system, when they processed and reported 324 patient samples from from January 1, 2024 to March 5, 2024. B. Based on chemistry quality control records review and laboratory director interview on March 19, 2025 at 12:00 PM, it was determined that the laboratory failed to verify the stated value of the new lot of control materials, when the laboratory processed and reported 500 Complete Metabolic Panel (CMP) patient samples from January 1, 2024 to May 31, 2024. The findings include: 1. The laboratory performs chemistry CMP tests with the Randox Daytona RX system. 2. The chemistry quality control records reviewed on March 19, 2025 at 12:00 PM, from January 1, 2024 to May 31, 2024, showed that there was no evaluation of the manufacturer's stated values for the lot numbers 1534UN (normal control level), and 534UE (abnormal control level) prior to placing them in routine use on January 1, 2024. 3. The laboratory director stated on March 19, 2025 at 12:00 PM, that no evaluations of the stated lots of control materials were performed prior to placing them in routine use. 4. The laboratory director confirmed on March 19, 2025 at 12:05 PM, that the laboratory failed to evaluate the stated value of the new lot of control materials for chemistry CMP tests performed by the Randox Daytona RX system, when they processed and reported 500 patient samples from from January 1, 2024 to May 31, 2024. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on review of the hematology and chemistry quality control records, and interview with the laboratory director on March 19, 2025 at 12:05 PM; it was determined that the laboratory director failed to fulfill her responsabilities and duties to ensure compliance with the hematology and chemistry quality control requirements. Refer to D5469. -- 2 of 2 --

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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 P.R.Proficiency Testing Program (PRPTP) records (years 2017, 2018 and 2019) review and laboratory director interview on March 28, 2019 at 9:20 AM, it was determine that the laboratory failed to take and document