Lab Clinico Y Bact Oriental

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 8, 2024 to Laboratorio Clnico y Bateriolgico Oriental, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1441 Laboratory Director, high complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing (PRPT) scores (year 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Sodium and Urea Nitrogen (BUN) tests. Refer to D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: A. Based on review of proficiency testing scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful performance in two out three consecutive testing events for Sodium and BUN tests. The finding includes: 1. The Puerto Rico Proficiency and CASPER Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Sodium a. Third testing event for year 2023-0% b. Second testing event for year 2024 -0% Analyte: BUN a. Third testing event for year 2023 -20% b. Second testing event for year 2024 -40% 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 review of Puerto Rico proficiency testing scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for Sodium and BUN tests. Refer to D6079. 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 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 Puerto Rico proficiency testing scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation's for Sodium and BUN tests during the third testing event of year 2023 and second testing event of year 2024. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on hematology quality control records review in 2016-2018 and laboratory director interview on February 7, 2018 at 10:35 AM, it was determined that the laboratory failed to evaluate and define twice a year the relationship between the manual cell differential and automatic cell differential. The findings include: 1. The laboratory performed automatic cell differential by Excell Drew 22 and Mindray BC5390 hematology systems. 2. Quality controls records were reviewed from January 2016 to January 2018. 3. The laboratory director stated on February 7, 2018 that the laboratory failed to evaluate twice a year a relationship between the manual cell differential and automatic cell differential by hematology system one time a year. (September 2016 and August 2017). D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. 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 -- This STANDARD is not met as evidenced by: Based on review of quality assessment ( QA) written procedures, quality assessment records review in 2016-2018 and laboratory director interview on February 7, 2018 at 10:45 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate patient tests results for inconsistencies with patient information. The findings include: 1. The QA written procedures stated that the laboratory monitor and evaluate patient tests results for inconsistencies with patient information. 2. The quality assessment records showed that the laboratory did not evaluate nor document any test inconsistency since year 2016. 3. The laboratory director stated on February 7, 2018 at 10: 45 AM that information regarding test inconsistencies were not documented as established in the QA procedure manual since year 2016. 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 quality assessment (QA) records review in 2016-2018 and laboratory director interview on February 7, 2018 at 11:45 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for analytic systems. The findings include: 1. The laboratory failed to evaluate and define twice a year the relationship between the manual cell differential and automatic cell differential. Refer to D5775. 2. The laboratory failed to follow the established Quality Assessment Program to monitor and evaluate patient tests results for inconsistencies with patient information. Refer to D5777. 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 quality control records review in 2017-2018 and laboratory director interview at 11:45 AM on February 7, 2018, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. The findings include: 1. The laboratory failed to evaluate and define twice a year the relationship between the manual cell differential and automatic cell differential. Refer to D5775. 2. The laboratory failed to follow the established Quality Assessment Program to monitor and evaluate patient tests results for inconsistencies with patient information. Refer to D5777. D6094 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 Quality Assessment (QA) records review in 2017-2018 and laboratory director interview at 11:45 AM on February 7, 2018, it was determined that laboratory director failed to ensure compliance with quality assessment (QA) requirements. Refer to D5791. 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 quality control records review in 2016-2018 and laboratory director interview on February 7, 2018 at 11:45 AM, it was determined that the general supervisor failed to follow quality control procedures. The findings include: 1. The laboratory failed to evaluate and define twice a year the relationship between the manual cell differential and automatic cell differential. Refer to D5775. 2. The laboratory failed to follow the established Quality Assessment Program to monitor and evaluate patient tests results for inconsistencies with patient information. Refer to D5777. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high 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 quality control records review in 2016-2018 and laboratory director interview on February 7, 2018 at 11:45 AM, it was determined that testing personnel failed to follow quality control procedures. The findings include: 1. The laboratory failed to evaluate and define twice a year the relationship between the manual cell differential and automatic cell differential. Refer to D5775. 2. The laboratory failed to follow the established Quality Assessment Program to monitor and evaluate patient tests results for inconsistencies with patient information. Refer to D5777. -- 3 of 3 --