Laboratorio Clinico Figueroa

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Figueroa on January 12, 2026. 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 January 12, 2026. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 manufacturer's specifications, lack of hematology preventive maintenance records review ( 10/2025-1/26) and laboratory general supervisor interview on January 12, 2026 at 10:40 AM, the laboratory failed to perform and document the preventive maintenance as required by the manufacturer of the Sysmex XN-550 hematology instrument, when they processed and reported 246 Complete Blood Count (CBC) tests from October 2025 to January 12, 2026. The findings include: 1. The laboratory begin to use the Sysmex XN-550 hematology instrument to perform CBC patient tests in October 2025. 2. . The manufacturer's specifications establishes that the daily and weekly maintenance of the Sysmex XN-550 hematology instrument are the following: shutdown and routine cleaning. 3. On January 12, 2026 at 10:40 AM, review of preventive maintenance records from October 2025 to January 12, 2026 , showed that the laboratory did not perform nor document the daily and monthly preventive maintenance of the hematology instrument. 4. The laboratory processed and reported 302 CBC sample tests from October 2025 to January 12, 2026. 5. 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 4 -- laboratory general supervisor confirmed on January 12, 2026, at 10:50 AM, that the laboratory failed to follow the manufacturer's specifications for the preventive maintenance of the Sysmex XN-550 hematology instrument. 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 chemistry quality control records review (years 2024 - 2025) and laboratory general supervisor interview on January 12, 2026 at 11:50, the laboratory failed to verify the stated value of the new lot of control materials, when the laboratory processed and reported 840 routine chemistry patient samples from November 3, 2025 to January 12, 2026. The findings include: 1. The laboratory performs chemistry routine chemistry tests by Dimension EXL-200 system. 2. On January 12, 2026 at 11: 50 AM, the chemistry quality control records review (years 2024 - 2025), showed that there was no evaluation of the manufacturer's stated values for the lot numbers CHA26081-A (control level 1), and OCR25112 (control level 2) prior to placing them in routine use on November 3, 2025. 3. The laboratory general supervisor confirmed on January 12, 2026 at 11:55AM, that the laboratory failed to evaluate the stated value of the new lot of control materials for routine chemistry tests performed by the EXL- 200 system prior to begin to test patients samples. 4. The laboratory processed and reported 840 routine chemistry patient samples from November 3, 2025 to January 12, 2026. 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: A. Based on Mycoplasma pneumoniae quality control records review (year 2025) and laboratory general supervisor interview on January 12, 2026 at 11:10 A.M., the laboratory did not evaluate the new lots of Mycoplasma pneumoniae test for positive and negative reactivity prior to placing it in routine use on September 3, 2025. The findings include: 1. The laboratory performed a Mycoplasma Pneumoniae test by Immuno Card method. 2. The Mycoplasma Pneumoniae quality control records were -- 2 of 4 -- reviewed from January 2, 2025 to January 12, 2026 and showed that the laboratory did not evaluate the new lot of Mycoplasma pneumoniae test for positive and negative reactivity prior to placing it in routine use: - Lot Number: 7090304328, Expiration date :10/1/2026, Date opened: 9/3/25, Patient processed and reported: 250 patients 3. The laboratory performed and reported 250 out of 250 Mycoplasma Pneumoniae patient samples from September 3, 2025 to December 13, 2025. 4. The laboratory general supervisor confirmed on January 12, 2026 at 11:15 A.M., that the laboratory did not evaluate the new lot of Mycoplasma Pneumoniae test for positive and negative reactivity prior to placing it in routine use. B. Based on human chorionic gonadotropin (hCG) test quality control records review (year 2025) and laboratory general supervisor interview on January 12, 2026 at 11:30 A.M, that the laboratory did not evaluate the new lots of hCG test for positive and negative reactivity prior to placing it in routine use on October 17, 2025. The findings include: 1. The laboratory performed hCG test by Aimstep method. 2. The hCG quality control test records were reviewed from January 2, 2025 to January 12, 2026 and showed that the laboratory did not evaluate the new lot of hCG test for positive and negative reactivity prior to placing it in routine use: Lot Number: 43532, Expiration date :4/30/2027, Date opened: 10/17/25. 3. The laboratory performed and reported 12 out of 12 hCG patient samples since October 17, 2025 to December 12, 2025 4. The laboratory general supervisor confirmed on January 12, 2026 at 11:35 A.M., that the laboratory did not evaluate the new lot of hCG test for positive and negative reactivity prior to placing it in routine use. C. Based on Rapid Plasma Reagin (RPR) test quality control records review (year 2025) and laboratory general supervisor interview on January 12, 2026 at 11:20 A.M, the laboratory did not evaluate the new lots of RPR test for positive and negative reactivity prior to placing it in routine use on August 2025. The findings include: 1. The laboratory performed RPR test by germaine method. 2. The RPR quality control test records were reviewed from January 2, 2025 to January 12, 2026 and showed that the laboratory did not evaluate the new lot of RPR test for positive and negative reactivity prior to placing it in routine use: Lot Number: 501505, Expiration date : 2/28/2026, Date opened: 8/2025. 3. The laboratory performed and reported 210 out of 210 RPR patient samples since August 2025 to December 15, 2025. 4. The laboratory general supervisor confirmed on January 12, 2026 at 11:25 A. M., that the laboratory did not evaluate the new lot of RPR test for positive and negative reactivity prior to placing it in routine use. D. Based on Infectious mononucleosis test ( IM test ) quality control records review (year 2025) and laboratory general supervisor interview on January 12, 2026 at 11:15 A.M, the laboratory did not evaluate the new lots of IM test for positive and negative reactivity prior to placing it in routine use on December 2025. The findings include: 1. The laboratory performed IM test by germaine method. 2. The IM quality control test records were reviewed from January 2, 2025 to January 12, 2026 and showed that the laboratory did not evaluate the new lot of IM test for positive and negative reactivity prior to placing it in routine use: Lot Number: L5A17BA, Expiration date : 1/27 Date opened: 12/15/25. 3. The laboratory performed and reported 5 out of 5 IM patient samples. 4. The laboratory general supervisor confirmed on January 12, 2026 at 11:15 A.M., that the laboratory did not evaluate the new lot of IM test for positive and negative reactivity prior to placing it in routine use. E. Based on Rheumatoid Arthritis test ( RA test ) quality control records review (year 2025) and laboratory general supervisor interview on January 12, 2026 at 11:25 A.M, the laboratory did not evaluate the new lots of RA test for positive and negative reactivity prior to placing it in routine use on December 2025. The findings include: 1. The laboratory performed RA test by germaine method. 2. The RA quality control test records were reviewed from January 2, 2025 to January 12, 2026 and showed that the laboratory did not evaluate the new lot of RA test for positive and negative reactivity prior to placing it -- 3 of 4 -- in routine use: Lot Number: 501501, Expiration date : 1/31/26 Date opened: 4/9/25. Lot Number: 516701, Expiration date : 8/31/26 Date opened: 10/22/25. 3. The laboratory performed and reported 34 out of 34 IM patient samples. 4. The laboratory general supervisor confirmed on January 12, 2026 at 11:25 A.M., that the laboratory did not evaluate the new lot of RA test for positive and negative reactivity prior to placing it in routine use. 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 hematology, routine chemistry tests, General Immunology, endocrinology , syphilis serology quality control records and interview with the laboratory general supervisor on January 12, 2026 at 12:30 PM, the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D5429 , D5469 and D5471. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on hematology, routine chemistry tests , general immunology , endocrinology and syphilis serology quality control records and interview with the laboratory general supervisor on January 12, 2026 at 12:30 PM, the laboratory general supervisor failed to fulfill her responsibilities and duties to ensure compliance with laboratory quality control requirements. Refer to D5429 , D5469 and D5471. -- 4 of 4 --

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, hematology quality control records review and laboratory technical supervisor (# 1) interview on February 11, 2022 at 10:16 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for hematology (CBC) tests from December 6, 2021 to January 10, 2022. Refer to D 5417 (The laboratory laboratory used the CBC controls materials that have exceeded their expiration date when 246 out of 246 patients specimens were tested and reported for CBC tests from December 6, 2021 to January 10, 2022). D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation, hematology quality control records review and laboratory technical supervisor (# 1) interview on February 11, 2022 at 10:16 AM, it was determined that the laboratory failed to used the CBC (complete blood count) controls materials that have exceeded their expiration date when 246 out of 246 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 -- patients specimens were tested and reported for CBC from December 6, 2021 to January 10, 2022. The findings include: 1. The laboratory analyzed and reported CBC patient's specimens by the DxH 520 system. 2. On February 11, 2022 at 10:16 AM, the Levy Jennings Charts showed that the laboratory used the following Coulter DxH series controls materials with exceeded their expiration date from December 6, 2021 to January 10, 2022: a. lot 372112911 exp date 12/05/2021. b. lot 372112912 exp date 12/05/2021. c. lot 372112913 exp date 12/05/2021. 3. The laboratory technical supervisor confirmed on February 11, 2022 at 10:16 AM, that the laboratory used those controls materials with exceeded their expiration date. She stated that due to the Covid Pandemic the laboratory had problems with those controls shipping. 4. The laboratory processed and reported 246 out of 246 patients specimens were tested for CBC from December 6, 2021 to January 10, 2022. 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 direct observation, hematology quality control records review and laboratory technical supervisor (# 1) interview on February 11, 2022 at 10:16 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system requirements for the CBC tests. Refer to D 6093.(The laboratory director failed to maintain the quality control procedures for the CBC tests from December 6, 2021 to January 10, 2022). 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 direct observation, hematology quality control records review and laboratory technical supervisor (# 1) interview on February 11, 2022 at 10:16 AM, it was determined that the laboratory director failed to maintain the quality control procedures for the CBC tests from December 6, 2021 to January 10, 2022. Refer to D 5024 (The laboratory failed to ensure compliance with the analytic system requirements for hematology (CBC) tests from December 6, 2021 to January 10, 2022). -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) record (years 2018 to 2020), Rubella qualitative testing records (years 2019 to 2020) review and laboratory technical supervisor interview at 11:10 AM on February 14, 2020, it was determined that the laboratory failed to enroll in an HHS approved Proficiency Testing Program for Rubella qualitative tests when it processed and reported 14 out of 14 patient's Rubella qualitative specimens from January 11, 2019 to February 14, 2020. The findings include: 1. At 11:10 AM on February 14, 2020, the PRPTP records showed that the laboratory did not enroll in an HHS approved Proficiency Testing Program for Rubella qualitative tests from January 11, 2019 to February 14, 2020. 2. The technical supervisor confirmed at 11:10 AM on February 14, 2020, that the laboratory performed Rubella qualitative tests form January 11, 2019 to February 14, 2020. However, the PRPTP net showed that this tests was removed for the year 2019 and the laboratory did not enroll for this year. 3. The laboratory processed and reported 14 out of 14 patient's Rubella qualitative specimens from January 11, 2019 to February 14, 2020. 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 -- 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 Rubagen manufacturer's instructions, Rubella qualitative testing records (years 2019 to 2020) review and laboratory technical supervisor interview at 11:10 AM on February 14, 2020, it was determined that the laboratory failed to follow manufacturer's instruction for the quality control procedures when it processed and reported 14 out of 14 patient's Rubella qualitative specimens from January 11, 2019 to February 14, 2020. The findings include: 1. The laboratory performed the Rubella qualitative test using the undiluted patient's serum qualitative technique. 2. At 11:10 AM on February 14, 2020, the Rubagen manufacturer instructed the laboratory that when testing undiluted serum for the qualitative technique procedures specimens, the low positive and negative control should be used undiluted. 3. The technical supervisor confirmed at 11:10 AM on February 14, 2020, that the laboratory used each day of testing the high positive control besides the negative control instead low positive control besides the negative control form January 11, 2019 to February 14, 2020. 4. The laboratory processed and reported 14 out of 14 patient's Rubella qualitative specimens from January 11, 2019 to February 14, 2020. 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 PRPTP record (years 2018 to 2020), Rubagen manufacturer's instructions, Rubella qualitative testing records (years 2019 to 2020) review and laboratory technical supervisor interview at 11:10 AM on February 14, 2020, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the Proficiency Testing Program and the laboratory analytical system requirements. Refer to D 6079 (The laboratory director did not ensure that the laboratory is enrolled in an HHS approved Proficiency Testing Program for Rubella qualitative tests). Refer to D 6093 (The 4, 2020, it was determined that the laboratory director did not comply with the analytic system requirement for the Rubella qualitative test). D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory -- 2 of 3 -- director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on PRPTP record (years 2018 to 2020), Rubella qualitative testing records (years 2019 to 2020) review and laboratory technical supervisor interview at 11:10 AM on February 14, 2020, it was determined that the laboratory director failed to ensure that the laboratory is enrolled in an HHS approved Proficiency Testing Program for Rubella qualitative tests from January 11, 2019 to February 14, 2020. Refer to D 2000. 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 Rubagen manufacturer's instructions, Rubella qualitative testing records (years 2019 to 2020) review and laboratory technical supervisor interview at 11:10 AM on February 14, 2020, it was determined that the laboratory director failed to comply with the analytic system requirement for the Rubella qualitative tests from January 11, 2019 to February 14, 2020. Refer to D 5405. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for 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 Rubagen manufacturer's instructions, Rubella qualitative testing records (years 2019 to 2020) review and laboratory technical supervisor interview at 11:10 AM on February 14, 2020, it was determined that the technical supervisor failed to comply with the analytic system requirement for the Rubella qualitative tests from January 11, 2019 to February 14, 2020. Refer to D 5405. -- 3 of 3 --

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(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 records reviewed and laboratory general supervisor interview on February 27, 2018 at 11:00 A..M., it was determined that the laboratory failed to take and document