Laboratorio Clinico Ginara

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Ginara on February 4, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During a recertification survey on February 4, 2026, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1212 Condition: Endocrinology 42 CFR 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, 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 Human Chorionic Gonadotropin (hCG) quality control records review (years 2024 - 2026) and interview with the laboratory director on February 4, 2026, at 1:25 PM, it was determined that the laboratory failed to meet the quality control requirements for Endocrinology specialty. Refer to D5449. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on the Human Chorionic Gonadotropin (hCG) quality control records review 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 -- (years 2024-2026), and laboratory director interview on February 4, 2026 at 1:25 PM, the laboratory failed to include an external negative and positive control material, each day of patient testing. The laboratory processed and reported 19 hCG patient samples from October 10, 2025 to December 17, 2025. The findings include: 1. The laboratory uses the AimStep Combo Pregnancy kit to perform the hCG tests. 2. Review of the hCG test quality control records (years 2024-2026), on February 4, 2026 at 1:19 PM, showed that the laboratory failed to include an external negative and positive control material, each day of patient testing, when the laboratory processed and reported 19 patient samples from October 10, 2025 to December 17, 2025. 3. The laboratory director confirmed on February 4, 2026 at 1:25 PM, that the laboratory failed to perform the external negative and positive control material each day of patient testing. The laboratory processed and reported 19 patient samples from October 10, 2025 to December 17, 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: Based on urinalysis quality control records review (years 2024-2026) and laboratory director interview on February 4, 2026 at 12:43 PM, it was determined that the laboratory failed to verify the stated value of the new lot of control materials (normal and abnormal controls), when the laboratory processed and reported 487 patient urinalysis samples from January 1, 2025 to February 4, 2026. The findings include: 1. The laboratory performs urinalysis tests with the Mission U500 Urine Analyzer instrument and uses UA liquid Controls Germaine control material. 2. The urinalysis quality control records reviewed (years 2024-2026) on February 4, 2026 at 12:37 PM, from January 1, 2025 to February 4, 2026, showed that there was no evaluation of the manufacturer's stated values for the normal and abnormal kit control material lot number 50941 prior to placing them in routine use on January 1, 2025. 3. The laboratory director stated on February 4, 2026 at 12:43 PM, that no evaluations of the stated lot of control materials were performed prior to placing them in routine use. 4. The laboratory director confirmed on February 4, 2026 at 12:43 PM, that the laboratory failed to evaluate the stated value of the new lot of control materials for urinalysis tests performed by the Mission U500 Urine Analyzer instrument, when they processed and reported 487 patient samples from January 1, 2025 to February 4, 2026. 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on Human Chorionic Gonadotropin (hCG) and urinalysis quality control records review (years 2024-2026), and laboratory director interview on February 4, 2026 at 1:25 PM, it was determined that the laboratory director failed to fulfill her responsabilities and duties to ensure compliance with the quality control requirements. Refer to D6007. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on Human Chorionic Gonadotropin (hCG) and urinalysis quality control records review (years 2024-2026), and laboratory director interview on February 4, 2026 at 1:25 PM, it was determined that the laboratory director failed to fulfill her responsabilities and duties to ensure compliance with the hCG and urinalysis quality control requirements. Refer to D5449 and D5469. -- 3 of 3 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the urinalysis quality control records and laboratory supervisor interview on January 10, 2024 at 11:10 AM, it was determined that the laboratory did not include or document a negative microscopic control material for manual microscopic urinalysis examinations, when 8,726 patients were processed and reported from January 1, 2022 to January 10, 2024. The findings include: 1. The urinalysis quality control records were reviewed on January 10, 2024 at 11:10 AM. 2. The laboratory did not include or document a negative control material for urinalysis microscopy test. 3. The laboratory supervisor confirmed on January 10, 2024 at 11:15 AM, that no negative microscopy control was implemented from January 1, 2022 to January 10, 2024, when 8,726 patients were processed and reported. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies 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 -- and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Mycoplasma pneumoniae IgM test manufacturer's instructions, worksheet records review and laboratory supervisor interview on January 10, 2024 at 12:45 PM, it was determined that the laboratory failed to follow manufacturer's instructions to document the internal control each day of patient and control testing, when 658 patients were processed and reported from December 20, 2022 to January 10, 2024. The findings include: 1. The laboratory uses the Immunocard reagent kit to perform patient Mycoplasma pneumoniae IgM test. 2. The manufacturer's instructions stated that the laboratory must monitor and document the internal control to ensure the validity of the Mycoplasma pneumoniae IgM test performed. 3. The Mycoplasma pneumoniae IgM test worksheet records showed on January 10, 2024 at 12:45 PM, that the laboratory did not document the observed results of the internal procedural control each day of patient and control testing. 4. The laboratory processed and reported 658 Mycoplasma pneumoniae IgM patient samples from December 20, 2022 to January 10, 2024. 5. The laboratory supervisor confirmed on January 10, 2024 at 12:50 PM, that the laboratory failed to monitor and document the internal control each day of Mycoplasma pneumoniae IgM patient and control testing. 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: 1. Based on review of the urinalysis quality control records and laboratory supervisor interview on January 10, 2024 at 11:10 AM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control requirements of manual microscopic urinalysis examinations, when 8,726 patients were processed and reported from January 1, 2022 to January 10, 2024. Refer to D5445. 2. Based on Mycoplasma pneumoniae IgM test manufacturer's instructions, worksheet records review and laboratory supervisor interview on January 10, 2024 at 12:45 PM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the manufacturer's instructions and laboratory quality control requirements, when 658 patients were processed and reported from December 20, 2022 to January 10, 2024. Refer to D5479. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 Hematology quality control records review and laboratory general supervisor interview it was determined that the laboratory failed to take a

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 Puerto Rico Proficiency Testing Program (PRPTP) records review and laboratory general supervisor interview on January 31, 2020 at 9:15 AM, it was determined that the laboratory failed to take and document

Summary Statement of Deficiencies D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, 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 Immunostix-rpr manufacturer's instruction, syphilis serology testing record review and technical supervisor interview on February 7, 2018 at 11:05 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for syphilis serology tests. The finding includes: 1. The laboratory did not follow the Immunostix-rpr manufacturer's instruction when 42 out of 42 patients specimens were tested and reported for syphilis serology tests by the rapid plasma reagin (RPR) method from November 7, 2017 to December 23, 2017. Refer to D 5479. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of