Laboratorio Clinico Plaza Caparra

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Plaza Caparra on August 7, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The following standard level deficiencies were found during the unannounced routine CLIA recertification survey ending on August 7, 2025. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: A. Based on general chemistry calibration verification records review (years 2024- 2025) and interview with the laboratory director on August 7, 2025, at 11:00 AM, it 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 -- was determined that the laboratory did not perform the Vitamin B12 calibration verification procedure at least once every six months. The laboratory processed and reported 869 out of 2,691 Vitamin B12 patient tests from January 1, 2024, to August 6, 2025, without performing the required calibration verification. The findings include: 1. The laboratory used Roche Diagnostics Cobas e 411Analyzer to perform Vitamin B12 testing. (Reviewed on August 7,2025 at 11:00 AM) 2. Review of general chemistry calibration verification records showed that the laboratory failed to perform Vitamin B12 calibration verification procedure in the years 2024 and 2025. 3. The laboratory processed and reported 869 out of 2,691 Vitamin B12 patient testing from January 1, 2024, to August 6, 2025, without calibration verification. 4. On August 7, 2025, at 11:30 AM, the laboratory director confirmed that the laboratory did not perform Vitamin B12 the calibration verification procedure at least once every six months. B. Based on endocrinology calibration verification records review (years 2024-2025) and interview with the laboratory director on August 7, 2025, at 11:00 AM, it was determined that the laboratory did not perform the 25-hydroxyvitamin D (25-OH-D) calibration verification procedure at least once every six months. The laboratory processed and reported 1,354 out of 4,768 25-OH-D patient tests from January 1, 2024, to August 6, 2025, without performing the required calibration verification. The findings include: 1. The laboratory used the Roche Cobas e411Analyzer to perform 25-OH-D testing. (Reviewed on August 7,2025 at 11:00 AM) 2. Review of endocrinology calibration verification records showed that the laboratory failed to perform 25-OH-D calibration verification procedure in the years 2024 and 2025. 3. The laboratory processed and reported 1,354 out of 4,768, 25-OH- D patient testing from January 1, 2024, to August 6, 2025, without calibration verification. 4. On August 7, 2025, at 11:30 AM, the laboratory director confirmed that the laboratory did not perform 25-OH-D the calibration verification procedure at least once every six months. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 general chemistry and endocrinology quality control records review (years 2024-2025) and interview with the laboratory director on August 7, 2025, at 11:30 AM, it was determined that the laboratory director failed to fulfill her responsibility to ensure at least once every six months, the calibration verification procedures for the Vitamin B12 and 25-OH-D assay. Refer to D5439. -- 2 of 2 --

Summary Statement of Deficiencies D0000 T he laboratorio Clnico Plaza Caparra was found to be in substantial compliance with CLIA regulations (42 CFR Part 493, effective April 24, 2003). No deficiencies were cited as a result of an onsite survey performed on November 3, 2021. 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 Covid-19 report records review and laboratory director interview on November 3, 2021 at 12:00 PM, it was determined that the laboratory failed to report the Covid- 19 results as required for two out of ten days reviewed from May 3, 2021 to May 28, 2021. The findings include: 1. The laboratory utilized the Health Department instruction to send the Covid-19 results to the Bioportal. 2. The laboratory processed the Covid-19 test by the following methods: Covid-19 Rapid test, Covid-19 Antigen, Covid-19 molecular by ID Now and Covid PCR by Atila system. 3. On November 3, 2021 at 12:00 PM, Covid-19 reports records showed that the laboratory did not send the Covid-19 results in the required frequency (24 hrs) to the Bioportal in two out of ten days reviewed from May 3, 2021 to May 28, 2021: Date Patients Date tested specimens reports tested sent 05/05/2021 6 11/03/2021 05/07/2021 29 11/03 /2021 4. The laboratory director confirmed on on November 3, 2021 at 12:00 PM, that the laboratory did not send those Covid-19 results in the required frequency (24 hrs) to the Bioportal. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on bacteriology culture media plates quality control records review (from January 1, 2018 to September 11, 2019) and laboratory director and testing personnel on September 11, 2019 at 11:20 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements of bacteriology. The finding includes: 1. The laboratory did not check each batch of cultures media plates used at the laboratory for ability to support growth, selectivity and or inhibition and biochemical response from January 1, 2018. Refer to D 5477. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, 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 general immunology (Mycoplasma pneumoniae IgM) quality control records (from December 14, 2019 to September 11, 2019) review and laboratory director interview on September 11, 2019 at 10:45 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements of 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 -- General immunology. The finding includes: 1. The laboratory did not include each day of testing a negative and a positive control material when patients serum specimens were tested for qualitative Mycoplasma IgM by the Immuno Card Mycoplasma method. Refer to D 5449. 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 general immunology (Mycoplasma pneumoniae IgM) quality control records (from December 14, 2018 to September 11, 2019), Mycoplasma pneumoniae IgM worksheets review and interview with the laboratory director at 10:45 AM on September 11, 2019, it was determined that the laboratory failed to include each day of testing a negative and a positive control material when patients serum specimens were tested for qualitative Mycoplasma IgM by the Immuno Card Mycoplasma method. The findings include: 1. The laboratory performed the IgM to Mycoplasma pneumoniae qualitative test by the Mycoplasma Immuno Card method. 2. The General Immunology serology (IgM to Mycoplasma pneumoniae) quality control records showed that the laboratory place in use the following lots of Mycoplasma Immuno Card: December 14, 2019 (lot # 709030K020), February 18, 2019 (lot # 709030K035), February 23, 2019 (lot # 709030K042), March 13, 2019 (lot # 709030K042), April 3, 2019 (lot # 709030K042) and September 9, 2019 (lot # 709030L046). 3. The Mycoplasma IGM quality control records showed that the laboratory did not include each day of testing a negative and a positive control material when 115 out of 115 patients serum specimens tested for qualitative Mycoplasma pneumoniae IgM by the Immuno Card Mycoplasma method from December 14, 2018 to September 11, 2019. The worksheets showed that 31 patients serum specimen tests were positive for Mycoplasma pneumoniae IgM and 84 patients serum tests were negative. 3. The laboratory director and testing personnel confirmed on September 11, 2019 at 10:45 AM, that the laboratory did not include each day of testing a negative and a positive control material when patients serum specimens were tested for qualitative Mycoplasma IgM. The laboratory director stated that the laboratory included a negative and a positive control material when they placed in use a box (same lot) or new lot of the Immuno Card Mycoplasma reagents kit. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on bacteriology culture media quality control records review (from January 10, 2018 to September 11, 2019), bacteriology worksheets and laboratory director and testing personnel interview on September 11, 2019, it was determined that the laboratory failed to check each batch of cultures media plates used at the laboratory for ability to support growth, selectivity and or inhibition and biochemical response since January 1, 2018. The findings include: 1. Review of the bacteriology culture media quality control records showed that the following agar plates were being used: Blood Agar (BA) and Mac Conkey. 2. From January 10, 2018 to September 11, 2019, the laboratory received the following: Media Total of different lot numbers a. Blood Agar (BA) 22 lots b. Mac Conkey 19 lots 3. The laboratory processed 756 patients samples for urine cultures from January 1, 2018 to September 11, 2019. The worksheets showed that 133 patients samples for urine cultures were positive and 623 patients samples for urine cultures were negative. 4. The laboratory director and testing personnel stated that no evaluation of the ability to support growth was performed from January 1, 2018 to September 11, 2019. 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 bacteriology (culture media plates) and general immunology (Mycoplasma pneumoniae IgM) quality control records review (from January 1, 2018 to September 11, 2019) and laboratory director interview on September 11, 2019 at 1:42 PM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the analytic system requirements of bacteriology and general immunology. Refer to D6093. 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 bacteriology and general immunology quality control (from January 1, 2018 to September 11, 2019) records review and laboratory director and testing personnel interview on September 11, 2019 at 1:50 PM, it was determined that the laboratory director did not establish quality control procedures for Mycoplasma pneumoniae test nor for bacteriology culture media plates. The findings include: 1. The laboratory did not include each day of testing a positive and negative control materials for Mycoplasma pneumoniae tests. Refer to D 5449. 2. The laboratory did not check the ability to support growth, inhibitor and or selectivity of the culture media plates. Refer to D5477. -- 3 of 3 --