Laboratorio Clinico Rosario

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced Clinical Laboratory Improvement Amendments (CLIA) recertification survey at Laboratorio Clnico Rosario on August 5, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During a recertification survey on August 5, 2026, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1212 ENDOCRINOLOGY 42 CFR 493.1403 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 endocrinology quality control records review (years 2024 - 2026) and interview with the Technical Consultant (CT) on August 5, 2026, at 1:00 p.m., the laboratory failed to ensure compliance with the analytic system requirements for Endocrinology test. Refer to D5449 (A). D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 2024 - 2026), Hematology Proficiency Testing (PT) scores (year 2025), and interview with the Technical Consultant (CT) on August 5, 2026, at 10:34 a.m., the laboratory failed to evaluate the accuracy of patient testing for the Hematology specialty (Complete Blood Count (CBC) and White Blood Cell (WBC) 5-Parameter testing), when the PT provider assigned an artificial score of 100 percent. The laboratory processed and reported 2,358 out of 2,358 CBC patient tests from June 2025 through November 2025. The findings include: 1. CASPER and PRPTSP (Hematology PT) scores were reviewed from May 2024 through August 2026. 2. Review of the hematology PT scores for the third testing event in 2025 showed that the PT provider assigned an artificial score of 100 percent for CBC and WBC 5-Parameters testing. The results were not evaluated. 3. During interview on August 5, 2026, at 10:34 a.m., with the Technical Consultant (CT), the evaluation of the accuracy of the excused Hematology specialty (Complete Blood Count (CBC) and White Blood Cell (WBC) 5- Parameter) was required. The CT stated that the laboratory did not evaluate the accuracy of the CBC and WBC (5- Parameter). 4. The laboratory processed and reported 2,358 out of 2,358 CBC patient tests from June 2025 through November 2025. 5. The Technical Consultant (CT) confirmed on August 5, 2026, at 11:15 a.m., that the laboratory did not evaluate the accuracy of the Hematology specialty test. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's written procedure manual, Mycoplasma patient testing worksheet and interview with the Technical Consultant (CT) on August 5, 2026, at 1:30 p.m., the laboratory failed to have a written procedure for Mycoplasma pneumoniae testing. The laboratory performed and reported 210 of 210 Mycoplasma pneumoniae patient specimens from August 4, 2025, through July 27, 2026. The findings include: 1. The laboratory performed qualitative Mycoplasma pneumoniae testing using the ImmunoCard Mycoplasma test system. 2. On August 5, 2026, at 1:30 p.m., the laboratory's written procedure for Mycoplasma pneumoniae testing was requested. The laboratory did not provide a written procedure for Mycoplasma pneumoniae testing. 3. Review of the Mycoplasma patient testing worksheet showed, that the laboratory performed and reported 210 of 210 Mycoplasma pneumoniae patient specimens from August 4, 2025, through July 27, 2026. 4. On August 5, 2026, at 1:55 p.m., the Technical Consultant (CT) confirmed during interview that the laboratory did not have a written procedure for Mycoplasma pneumoniae testing. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for -- 2 of 8 -- specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at LABORATORIO CLINICO ROSARIO on July 16, 2024. 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 July 16, 2024. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphilis serology testing records (year 2023 and 2024) review and laboratory supervisor interview on July 16, 2024 at 11:37 AM, it was determined that the laboratory failed to include at least once a day, a negative control material and the control material with tittered reactivity when one (1) out of one (1) patient specimen were tested for syphilis serology by rapid plasma reagin (RPR) quantitative tests by ASI method on May 28, 2024. The findings include: 1. The laboratory processed and reported the RPR quantitative tests by ASI method. 2. On July 16, 2024 at 11:19 AM, the syphilis serology testing records showed that the laboratory did not include at least once a day, the negative control material and the control material with tittered reactivity. 3. The laboratory supervisor confirmed on July 16, 2024 at 11:37 AM, that the laboratory did not include the negative control material and the control material 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 -- with tittered reactivity when it performed the quantitative RPR test. One (1) out of one (1) patient specimen were tested for RPR quantitative tests by ASI method on May 28, 2024. 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 syphilis serology records review (year 2023 and 2024) and interview with the laboratory supervisor on July 16, 2024 at 11:37 AM; it was determined that the laboratory director failed to ensure that the quality control for tittered syphilis serology test were followed. Refer to D5451 -- 2 of 2 --

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 syphilis serology quality control records review, manufacturer's instructions and laboratory director interview on August 31, 2018 at 10:15 AM, it was determined that the laboratory failed to included meet the requirements for syphilis serology by Rapid Plasma Reagin (RPR) tests. Refer to D5411 and D5451. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on syphilis serology quality control records from January 2, 2018 to August 29, 2018, manufacturer's instructions review and laboratory director interview on August 31, 2018 at 10:15 AM, it was determined that the laboratory failed to follow manufacturer's instructions to perform the needle calibration each day of use as required by the ASI Rapid Plasma Reagin (RPR) method. The findings include: 1. The laboratory performed Rapid Plasma Reagin (RPR) by ASI method. 2. The manufacturer's requires that the laboratory must verify the needle calibration (0.5 ml - Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 30 1 drop) each day of use. 3. From January 2, 2018 to August 29, 2018, showed that the laboratory did not verify nor document the needle calibration in the RPR (Rapid Plasma Reagin) testing area in those days. 4. The laboratory processed and reported 459 RPR patient's samples tests from January 2, 2018 to August 29, 2018. 5. The laboratory director confirmed on August 31, 2018, that the laboratory did not verify and document the needle calibration from January 2, 2018 to August 29, 2018. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphilis serology quality control records review from January 2, 2018 to August 29, 2018 and laboratory director interview on August 31, 2018 at 10:13 AM, it was determined that the laboratory failed to include at least once a day , a negative control material and a control material with tittered reactivity when patients were tested for syphilis serology by Rapid Plasma Reagin (RPR) quantitative tests. The findings include: 1. The laboratory performed Rapid Plasma Reagin (RPR) by ASI RPR Reagents set. 2. Review of syphilis serology quality control from January 2, 2018 to August 29, 2018, showed that the laboratory did not include at least once a day, a negative control material and a control material with tittered reactivity when the following patient specimen was processed and report on May 14, 2018 (ID # 2018- 321, R 1:128 dils., ID # 2018-323, R 1:128 dils., ID # 2018- 324, R 1:128 dils), May 16, 2018 (ID # 204298, R 1:2 dils.) and July 25, 2018 (ID # 205832, R 1:4 dils.). 3. The laboratory director confirmed on August 31, 2018, that the laboratory did not include at least once a day, a negative control material and a control material with tittered reactivity when patients specimens were tested for syphilis serology quantitative those days. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, syphilis serology quality control records review and laboratory director interview on August 31, 2018 at 10:30 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following requirements for analytic systems: 1. failed to follow the manufacturer's instructions to verify and document the needle calibration. -- 2 of 4 -- Refer to D 5411. 2. failed to follow the manufacturer's instructions when patient specimen were tested for quantitative Rapid Plasma Reagin (RPR) by ASI. Refer to D5451. 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 manufacturer's instructions , quality control records review and laboratory director interview on August 31, 2018 at 11:56 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system and quality assessment requirements. The finding includes: 1. The laboratory director did not comply with the requirements for analytical systems and quality assessment requirements. Refer to D6020 and D6021. 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 manufacturer's instructions, quality control records review and laboratory director interview on August 31, 2018 at 11:56 AM, it was determined that the laboratory director failed to ensure compliance with requirements for analytic systems. The finding includes: 1. The laboratory director did not assure that the laboratory: a. failed to follow the manufacturer's instruction to verify and document the needle calibration. Refer to D5411. b. failed to follow the manufacturer's instructions when patient specimen were tested for quantitative Rapid Plasma Reagin (RPR) by ASI. Refer to D5451. D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on Quality Assessment (QA) records review and laboratory director interview on August 31, 2018 at 11:58 AM, it was determined that the laboratory director failed to ensure compliance with QUA requirements. The finding includes: 1. The laboratory director did not evaluate the established Quality Assessment Program to monitor and document the following requirement for analytic systems: a. failed to follow the manufacturer's instruction to verify and document the needle calibration. Refer to D 5411. b. failed to follow the manufacturer's instructions when patient specimen were tested for quantitative Rapid Plasma Regain (RPR) by ASI. Refer to D5451. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must 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 procedures manual, quality control records review and laboratory director interview on August 31, 2018, it was determined tat the testing personnel failed to follow the quality control requirements. The finding includes: 1. The laboratory testing personnel failed to following quality control procedures: a. failed to follow the manufacturer's instruction to verify and document the needle calibration. Refer to D 5411. b. failed to follow the manufacturer's instructions when patient specimen were tested for quantitative Rapid Plasma Regain (RPR) by ASI. Refer to D5451. -- 4 of 4 --