Laboratorio Clinico La 116

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 La 116 on August 18, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During a recertification survey on August 18, 2026, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1208 General Immunology 42 CFR 493.1403 Laboratory Director 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 review of the General Immunology (Mycoplasma) quality control records (years 2025-2026) and interview with the Laboratory Director (LD) on August 18, 2026, at 8:50 a.m., the laboratory failed to ensure compliance with the analytic system requirements for Mycoplasma testing. 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 review of the Mycoplasma pneumoniae quality control procedure, quality control records (years 2025-2026), patient testing records, and interview with the 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 -- laboratory director (LD) on August 18, 2026, at 8:50 a.m., the laboratory failed to include external negative and positive control materials each day of Mycoplasma pneumoniae patient testing. The laboratory performed and reported 598 out of 598 Mycoplasma pneumoniae patient specimens from January 4, 2025, through August 17, 2026. The findings included: 1. The laboratory performed qualitative Mycoplasma pneumoniae testing using the ImmunoCard Mycoplasma test system. 2. On August 18, 2026, at 8:50 a.m., the Mycoplasma quality control procedure was requested and reviewed. The procedure established that external positive and negative controls were processed with each new lot and each new shipment. 3. Review of the Mycoplasma pneumoniae quality control records showed that the laboratory did not include external negative and positive control materials each day of Mycoplasma pneumoniae patient testing. 4. Review of the patient testing records showed that the laboratory performed and reported 598 out of 598 Mycoplasma pneumoniae patient specimens from January 4, 2025, through August 17, 2026. 5. During interview on August 18, 2026, at 9:20 a.m., the laboratory director (LD) confirmed that the external negative and positive controls were not performed each day of Mycoplasma pneumoniae patient testing. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (1) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. This STANDARD is not met as evidenced by: Based on review of the Mycoplasma pneumoniae quality control records (years 2025- 2026), patient testing records, and interview with the laboratory director (LD) on August 18, 2026, at 9:05 a.m., the laboratory did not evaluate new lots of Mycoplasma pneumoniae test kits for positive and negative reactivity before placing them into routine use. The laboratory performed and reported 591 out of 591 Mycoplasma pneumoniae patient specimens from January 2, 2025, through August 17, 2026. The findings included: 1. The laboratory performed qualitative Mycoplasma pneumoniae testing using the ImmunoCard Mycoplasma test system. 2. Review of the Mycoplasma pneumoniae quality control and patient testing records showed that the laboratory did not evaluate the following new lots for positive and negative reactivity before placing them into routine use: a. ImmunoCard Mycoplasma - Lot 78651134 Expiration date: 2/14/2026 Used dates: 11/23/2024 through 1/8/2025 Patient specimens performed and reported: 7 b. ImmunoCard Mycoplasma - Lot 78651132 Expiration date: 01/01/2026 Used dates: 1/8/2025 through 2/14/2025 Patient specimens performed and reported: 84 c. ImmunoCard Mycoplasma - Lot 78651144 Expiration date: 5/13/2026 Used dates: 2/19/2025 through 4/8/2025 Patient specimens performed and reported: 91 d. ImmunoCard Mycoplasma - Lot 78651155 Expiration date: 8/12/2026 Used dates: 4/8/2025 through 4/26/2025 Patient specimens performed and reported: 23 e. ImmunoCard Mycoplasma - Lot 78651151 Expiration date: 8/12 /2026 Used dates: 4/8/2025 through 9/3/2025 Patient specimens performed and reported: 136 f. ImmunoCard Mycoplasma - Lot 7865.1163 Expiration date: 10/23 /2026 Used dates: 9/3/2025 through 1/16/2026 Patient specimens performed and reported: 109 g. ImmunoCard Mycoplasma - Lot 7865.1174 Expiration date: 2/5/2027 -- 2 of 3 -- Used dates: 1/16/2026 through 5/18/2026 Patient specimens performed and reported: 109 h. ImmunoCard Mycoplasma - Lot 7865.1183 Expiration date: 6/17/2027 Used dates: 5/23/2026 through 8/10/2026 Patient specimens performed and reported: 24 i. ImmunoCard Mycoplasma - Lot 7865.11835 Expiration date: 7/14/2027 Used dates: 8 /10/2026 through 8/17/2026 Patient specimens performed and reported: 8 3. Review of the patient testing records showed that the laboratory performed and reported 591 out of 591 Mycoplasma pneumoniae patient specimens from January 2, 2025, through August 17, 2026. 4. During interview on August 18, 2026, at 9:20 a.m., the laboratory director (LD) confirmed that the new lots of Mycoplasma pneumoniae test kits were not evaluated for positive and negative reactivity before being placed into routine use. 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 Mycoplasma pneumoniae IgM quality control records, patient testing records, and interview with the laboratory director (LD) on August 18, 2026, at 12:30 p.m., the laboratory director failed to fulfill the responsibility to ensure that Mycoplasma pneumoniae IgM testing was performed in compliance with applicable quality control requirements. Refer to D6020. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 review of Mycoplasma pneumoniae IgM quality control records, patient testing records, and interview with the laboratory director (LD) on August 18, 2026, at 12:30 p.m., the laboratory director failed to ensure compliance with quality control requirements for Mycoplasma pneumoniae IgM testing, including the performance of required external positive and negative controls each day of patient testing and the evaluation of new test kit lots before routine patient testing. Refer to D5449 and D5471. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The Laboratorio Clnico La 116 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 July 12, 2024. 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 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 Immunostic manufacturer's instructions for qualitative rapid plasma reagin ( RPR) test, RPR quality control record review and technical consultant interview on September 13, 2018 at 10:50 AM, it was determined that the laboratory failed to meet the subspecialty of Syphilis serology for qualitative RPR test. Refer to D 5405 (The laboratory did not follow the quality control procedures when 8 out of 8 patients specimens were tested for qualitative RPR from June 13, 2018 to July 24, 2018). D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on Immunostic manufacturer's instructions for qualitative rapid plasma reagin ( RPR) test, RPR quality control record review and technical consultant interview on September 13, 2018 at 10:50 AM, it was determined that the laboratory failed to follow quality control procedures when 8 out of 8 patients specimens were tested for 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 -- qualitative RPR from June 13, 2018 to July 24, 2018. The findings included: 1. The laboratory used the Immunostic RPR reagent kit (antigen lot 9495) from June 8, 2018 to August 11, 2018. 2. The Immunostic manufacturer's instructed the laboratory to include three control materials each day of testing (non reactive, weakly reactive and reactive). 3. The RPR quality control record showed that the laboratory did not include each day of testing the three control materials when 8 out of 8 patients specimens were tested for qualitative RPR from June 13, 2018 to July 24, 2018: Date request Date reported sample ID June 13, 2018 June 15, 2018 #30524 June 27, 2018 June 27, 2018 #30952 June 27, 2018 June 28, 2018 #30940 June 27, 2018 June 28, 2018 #30942 June 27, 2018 June 28, 2018 #30947 June 27, 2018 June 28, 2018 #30962 July 24, 2018 July 24, 2018 #31709 July 24, 2018 July 24, 2018 #31712 4. The technical consultant confirmed on September 13, 2018 at 10:55 AM, that the quality control record for the RPR test did not include the result of the three control materials those days. She stated, that the laboratory performed the quality control procedures but not documented the controls result. 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 Immunostic manufacturer's instructions for qualitative rapid plasma reagin ( RPR) test, RPR quality control record, personnel file review, lack of technical consultant competence records and the technical consultant interview on September 13, 2017 at 11:15 AM, , it was determined that the laboratory director failed to fulfil her responsibilities and duties to comply with the analytic system and with the technical consultant competence. Refer to D6020 ( The laboratory director failed to ensure that the laboratory performed the quality control procedures when 8 out of 8 patients specimens were tested for qualitative RPR from June 13, 2018 to July 24, 2018). Refer to D 6030 ( The laboratory director failed to ensure that policies and procedures were established for monitoring the competence of the technical consultant since January 2017). 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 Immunostic manufacturer's instructions for qualitative rapid plasma reagin ( RPR) test, RPR quality control record review and technical consultant interview on September 13, 2018 at 10:50 AM, it was determined that the laboratory director failed to ensure that the laboratory performed the quality control procedures when 8 out of 8 -- 2 of 3 -- patients specimens were tested for qualitative RPR from June 13, 2018 to July 24, 2018. Refer to D 5012 ( The laboratory failed to meet the subspecialty of Syphilis serology for qualitative RPR test). D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on personnel file review, lack of technical consultant competence records and the technical consultant interview on September 13, 2017 at 11:15 AM, it was determined that the laboratory director failed to ensure that policies and procedures were established for monitoring the competence of the technical consultant since January 2017. The findings include: 1. The technical consultant file showed that the laboratory director did not evaluate annually her performance as technical consultant since January, 2017. The laboratory director evaluated this personnel as general supervisor and testing personnel. 2. The technical supervisor confirmed that the laboratory director did not evaluate annually her performance as technical consultant since January 2017, 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 Immunostic manufacturer's instructions for qualitative rapid plasma reagin ( RPR) test, RPR quality control record review and technical consultant interview on September 13, 2018 at 10:50 AM, it was determined that the technical consultant failed to ensure that the laboratory performed the quality control procedures when 8 out of 8 patients specimens were tested for qualitative RPR from June 13, 2018 to July 24, 2018. Refer to D5405. -- 3 of 3 --