Laboratorio Clinico Laracuente

Summary Statement of Deficiencies D0000 An unannounced CLIA Recertification survey was conducted at the Laboratorio Clnico Laracuente on February 7, 2025 by the Puerto Rico State Agency. 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 on February 7, 2025. D2071 SYPHILIS SEROLOGY CFR(s): 493.835(c) (c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing (PRPT) event scores (years 2023- 2024), CASPER Report 0155D, PRPT (year 2024) schedule and laboratory director interview on February 7, 2025, at 9:00 A.M., it was determined that the laboratory failed to report the syphilis serology proficiency testing results within the time frame established by the program. The findings include: 1. The PRPT and CASPER Report were reviewed on February 7, 2025, at 9:00 A.M., from February 2023 to December 2024. 2. The PRPT schedule for year 2024 showed that the deadline of the first testing event for Diagnostic Immunology scores was April 19, 2024. (Reviewed on February 7, 2025, at 9:05 A.M.) 3. Review of the PRPT scores showed that the laboratory obtained a 0% score in the first testing event, year 2024, for syphilis serology tests. (Reviewed on February 7, 2025, at 9:10 A.M.) 4. The laboratory director confirmed on February 7, 2025, at 10:30 A.M., that the laboratory failed to report the syphilis serology proficiency testing results of the first testing event within the time frame established by the PRPT. D5471 CONTROL PROCEDURES 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 -- 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 human chorionic gonadotropin (hCG) test quality control records review (year 2024), hCG test new lot reactivity worksheet records and laboratory director interview on February 7, 2025 at 1:00 P.M, it was determined that the laboratory did not evaluate the new lots of hCG test for positive and negative reactivity prior to placing it in routine use, when 35 out of 35 patient specimens were processed and reported from April 29, 2024 to December 30, 2024. The findings include: 1. On February 7, 2025, at 1:00 P. M, the laboratory director stated that the laboratory performed qualitative hCG tests with the Instant-View Combo Cassettes. 2. The hCG quality control test records and hCG test new lot reactivity worksheet records were reviewed from January 2, 2024, to December 30, 2024, 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: 085391, Expiration date :7/31/25, Date opened: 4/29/24. 3. The laboratory performed and reported 35 out of 35 hCG patient samples. (Reviewed on February 7, 2025, at 1:07 P.M.) 4. The laboratory director confirmed on February 7, 2025, at 1:15 P.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. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program; This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing scores (years 2023-2024) and CASPER Report and laboratory director interview on February 7, 2025, at 10:40 A.M, it was determined that the laboratory director failed to report the Diagnostic Immunology proficiency testing results within the time frame established by the program, getting a score of 0% in the first event for syphilis serology. Refer to D2071. 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 endocrinology quality control (hCG test) record review and laboratory -- 2 of 3 -- director interview on February 7, 2025, at 1:30 P.M., it was determined that the laboratory director failed to ensure that the laboratory evaluated the new lot of hCG test for positive and negative reactivity prior to placing it in routine use. Refer to D5471. -- 3 of 3 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of validation records of the Beckman Coulter DxH520 system for the complete blood cells (CBC) tests and laboratory director interview on May 21, 2021 at 10:20 AM, it was determined that the laboratory failed to verify that the manufacturer's CBC reference intervals (normal values) are appropriate for the laboratory's patient population before reporting 1,420 out of 1,420 CBC patient results from January 4, 2021 to May 20, 2021. The findings include: 1. On May 21, 2021 at 10:20 AM, the Beckman Coulter DxH520 system records showed that the laboratory laboratory performed the validation procedures on December 16, 2020 and it did not verify that the manufacturer's CBC reference intervals (normal values) are appropriate for the laboratory's patient population. 2. The laboratory director confirmed on May 21, 2021 at 10:20 AM, that the laboratory did not verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population before reporting CBC patient results. 3. The laboratory processed and reported 1,420 out of 1,420 CBC patient results from January 4, 2021 to May 20, 2021. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 -- 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 review of validation records of the Beckman Coulter DxH520 system for the complete blood cells (CBC) tests and laboratory director interview on May 21, 2021 at 10:20 AM, it was determined that the laboratory director failed to ensure compliance with the requirements for CBC tests from January 4, 2021 to May 20, 2021. Refer to D5421 (The laboratory did not verify that the manufacturer's CBC reference intervals (normal values) are appropriate for the laboratory's patient population before reporting 1,420 out of 1,420 CBC patient results from January 4, 2021 to May 20, 2021. -- 2 of 2 --

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 manufacturer's instructions, Complete Blood Count (CBC) quality control (QC) records ( years 2017, 2018 and 2019) review and interview with the general supervisor on March 6, 2019 at 9:45 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for CBC tests. The finding includes: 1. Refer to D 5405. (The laboratory failed to follow manufacturer's instructions for the CBC QC procedures when 1,332 out of 1,332 patient specimens were tested for CBC by the Coulter Act 5 diff hematology system from January 6, 2018 to April 30, 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 manufacturer's instructions, Complete Blood Count (CBC) quality control records ( years 2017, 2018 and 2019) review and interview with the general supervisor on March 6, 2019 at 9:45 AM, it was determined that the laboratory failed 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 -- to follow manufacturer's instructions for the CBC quality control (QC) procedures when 1,332 out of 1,332 patient specimens were tested for CBC by the Coulter Act 5 diff hematology system from January 6, 2018 to April 30, 2018. The findings include: 1. The laboratory uses Coulter Act 5 diff system to perform the CBC tests. 2. The manufacturer establishes that three levels of control material (low, normal and high) must be included each day of testing. 3. On March 6, 2019 at 9:45 AM, review of CBC quality control records ( years 2017, 2018 and 2019) showed that the laboratory did not have available the QC data nor the Levey Jennings (LJ) charts of the three levels CBC control values for the following periods: from January 6, 2018 to January 31, 2018, from March 1, 2018 to March 23, 2018 and from April 8, 2018 to April 30, 2018. 4. The general supervisor confirmed on March 6, 2019 at 9:45 a.m., that the laboratory did not have available those CBC data nor the CBC control values LJ charts due to the Act 5 diff's information system was damage and those data were lost. 5. The laboratory processed and reported the following patients specimens from January 6, 2018 to April 30, 2018: a. From January 6, 2018 to January 31, 2018: 450 out of 450 CBC's patients specimens. b. From March 1, 2018 to March 23, 2018: 404 out of 404 CBC's patients specimens. c. From April 8, 2018 to April 30, 2018: 438 out of 438 CBC's patients specimens 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 manufacturer's instructions, Complete Blood Count (CBC) quality control (QC) records ( years 2017, 2018 and 2019), personnel records files and interview with the with the general supervisor on March 6, 2019 at 12:08 PM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system. The finding includes: 1. The laboratory director did not comply with the analytical systems requirements. Refer to D 6093. 2. The laboratory director did not ensure the competency of the laboratory general supervisor. Refer to D 6103. 3. The laboratory director did not specify in writing the duties and responsibilities of the laboratory general supervisor. Refer to D 6107. 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 manufacturer's instructions, Complete Blood Count (CBC) quality control (QC) records ( years 2017, 2018 and 2019) review and interview with the general supervisor on March 6, 2019 at 9:45 AM, it was determined that the laboratory director failed to ensure compliance with the analytic system requirements for CBC tests. Refer to D 5024. -- 2 of 3 -- D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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 review of personnel records files and interview with the with the general supervisor on March 6, 2019 at 12:08 PM, it was determined that the laboratory director did not ensure the competency of the laboratory general supervisor from January 9, 2017 to January 10, 2019. The findings include: 1. On March 6, 2019 at 9: 45 AM, the general supervisor personnel files did not include her competence evaluation from January 9, 2017 to January 10, 2019. 2. The laboratory director did not establish a written protocol to evaluate the competency of the laboratory general supervisor. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records files and interview with the with the general supervisor on March 6, 2019 at 12:08 PM, it was determined that the laboratory director did not specify in writing the duties and responsibilities of the laboratory general supervisor from January 9, 2017 to January 10, 2019. The finding includes: 1. On March 6, 2019 at 9:45 AM, the general supervisor personnel files did not include written duties nor responsibilities from January 9, 2017 to January 10, 2019. -- 3 of 3 --