Lab Clinico Santa Cruz

Summary Statement of Deficiencies D0000 An offsite Proficiency Test (PT) Desk Review was performed on October 16, 2025 to Laboratorio Clinico Santa Cruz, 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 in the analyte Hematocrit (HCT) tests. 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 CASPER 0155D and PRPTSP scores (year 2025), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) of two (2) consecutive testing events in a proficiency testing program approved by HHS, for hematology specialty for analyte Hematocrit (HCT) tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on September 30, 2025, confirmed that the laboratory had a PT failure for the analyte Hematocrit (HCT) tests. The laboratory obtained the following testing scores: Analyte: Hematocrit (HCT) a. First testing event year 2025 - 20% b. Second testing event year 2025 - 40% 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 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on Cobas c501 Module maintenance log information records, Cobas c501 module maintenance log records (years 2017 to 2018) review and technical consultant interview on June 7, 2018 at 10:50 AM, it was determined that the laboratory failed to follow manufacturer's instruction for preventive maintenance when the laboratory processed for the following tests by the Cobas c501 system from August 21, 2017 to June 6, 2018: 3,600 comprehensive metabolic panel (CMP) , 3,316 lipid profile and 2,188 glycohemoglobin). The findings include: 1. On June 7, 2018 at 10:50 AM, the Cobas c501 Module maintenance log information record showed that the Cobas c501 Module manufacturer instructed the laboratory to perform the following preventive maintenance: a. Replace the photometer lamp when the photometer reading at 340nm is > 14,000 or every 6 months whichever comes first. b. Replace every 2 months the reaction cells. c. Replace every 6 months the ISE Ref. Cartridge. 2. The Cobas c501 module maintenance log records showed that the laboratory did not replace the photometer lamp, the reaction cells nor the ISE Ref. Cartridge from August 21, 2017 to June 6, 2018. 3. The technical consultant confirmed on June 7, 2018 at 10:50 AM, that the laboratory did not perform the preventive maintenance of the Cobas c501 manufacturer instructions due to the laboratory followed the instructions for the preventive antennae from the Cobas c501 module technician. 4. From August 21, 2017 to June 6, 2018, the laboratory processed for the following tests by the Cobas c501 system: 3,600 CMP, 3,316 lipid profile and 2,188 glycohemoglobin. 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 -- D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on Cobas c501 Module maintenance log information records, Cobas c501 module maintenance log records (years 2017 to 2018) review and technical consultant interview on June 7, 2018 at 10:50 AM, it was determined that the laboratory director failed to ensure compliance with the analytic system for the routine chemistry tests results. The finding includes: 1. The laboratory director failed to ensure that the laboratory follow manufacturer's instruction for preventive maintenance when it processed for the following tests by the Cobas c501 system from August 21, 2017 to June 6, 2018: 3,600 CMP, 3,316 lipid profile and 2,188 glycohemoglobin). Refer to D 5429. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on Cobas c501 Module maintenance log information records, Cobas c501 module maintenance log records (years 2017 to 2018) review and technical consultant interview on June 7, 2018 at 10:50 AM, it was determined that the technical consultant failed to ensure that the laboratory follow manufacturer's instruction for preventive maintenance when it processed for the following tests by the Cobas c501 system from August 21, 2017 to June 6, 2018: 3,600 CMP, 3,316 lipid profile and 2,188 glycohemoglobin. Refer to D 5429. -- 2 of 2 --