Cdt- Sala De Emergencia Sanos

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico CDT Sala de Emergencias SANOS on May 13, 2025. 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 May 13, 2025. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) program review (years 2023-2025) and laboratory director interview on May 13, 2025, at 10:00 A.M., it was determined that the laboratory failed to follow the established QA program to monitor and evaluate the following requirements for General laboratory systems: patient confidentiality, specimen identification and integrity, complaint investigation and communications. The findings include: 1. On May 13, 2025, at 10:00 A.M., review of the laboratory QA program showed that the laboratory must evaluate, annually, the following: patient confidentiality. 2. On May 13, 2025, at 10:00 A.M., review of the laboratory QA program showed that the laboratory must evaluate, bi-annually, the following: specimen identification and integrity. 3. On May 13, 2025, at 10:00 A.M., a review of the laboratory QA program showed that the laboratory must evaluate, monthly, the following: complaint investigation and communications. 4. The record showed that the laboratory did not perform any QA evaluation since year 2024. 5. The laboratory director confirmed during the interview on May 13, 2025 at 10:00 A.M., that the general systems QA evaluations were not performed since the year 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 3 -- D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) (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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on quality assessment (QA) program review (years 2023-2025) and the laboratory director interview on May 13,2025, at 10:00 A.M., it was determined that the laboratory failed to follow the established QA Program to monitor and evaluate the following requirements for preanalytic systems: patient test requests and specimen submission, handling and referral. The findings include: 1. On May 13, 2025, at 10:00 A.M., review of the laboratory QA program showed that the laboratory must evaluate, annually, the following: specimen submission, handling and referral. 2. 1. On May 13, 2025, at 10:00 A.M., review of the laboratory QA program showed that the laboratory must evaluate, bi-annually, the following: patient test request. 3. The record showed that the laboratory did not perform any QA evaluation since year 2024. 4. The laboratory director confirmed during interview on May 13, 2025 at 10:00 A.M., that the preanalytic systems QA evaluations were not performed since the year 2023. 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. This STANDARD is not met as evidenced by: Based on quality assessment (QA) program review (years 2023-2025) and the laboratory director interview on May 13,2025, at 10:00 A.M., it was determined that the laboratory failed to follow the established QA Program to monitor and evaluate the following requirements for analytic systems: comparison of test results and patient test records. The findings include: 1. On May 13, 2025, at 10:00 A.M., a review of the laboratory QA program showed that the laboratory must evaluate, annually, the following: patient test records. 2. On May 13, 2025, at 10:00 A.M., review of the laboratory QA program showed that the laboratory must evaluate, bi-annually, the following: comparison of test results. 3. The record showed that the laboratory did not perform any QA evaluation since year 2024. 4. The laboratory director confirmed during an interview on May 13, 2025 at 10:00 A.M., that the analytic systems QA evaluations were not performed since for the year 2023. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on quality assessment (QA) program review (years 2023-2025) and the laboratory director interview on May 13,2025, at 10:00 A.M., it was determined that the laboratory failed to follow the established QA Program to monitor and evaluate the following requirements for postanalytic systems: patient test reports and turn around time. The findings include: 1. On May 13, 2025, at 10:00 A.M., review of the laboratory QA program showed that the laboratory must evaluate, annually, the following: patient test reports. 2. On May 13, 2025, at 10:00 A.M., review of the laboratory QA program showed that the laboratory must evaluate, bi-annually, the following: turn around time. 3. The record showed that the laboratory did not perform any QA evaluation since year2024. 4. The laboratory director confirmed during interview on May 13, 2025 at 10:00 A.M., that the postanalytic systems QA evaluations were not performed since for the year 2023. 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 quality assessment (QA) review (years 2023-2025) and laboratory director interview on May 13, 2025 at 10:00 A.M., it was determined that the laboratory director failed to ensure compliance with the quality assessment program. Refer to D5291, D5391, D5791 and D5891. -- 3 of 3 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) activities records review and laboratory director interview on May 12, 2023 at 10:00 AM, it was determined that laboratory failed to evaluate and monitor the patient confidentiality and complaint investigation in the General Laboratory system in the year 2022. The findings include: a. On May 12, 2023 at 9:31 AM, the laboratory QA was requested. The QA showed that the laboratory has established in the evaluation of patient confidentiality that what would be evaluated annually and the complaint investigation that what would be evaluated monthly. b. On May 12, 2023 at 9:40 AM the QA showed that the laboratory failed to evaluate and monitor the patient confidentiality in the year 2022 and failed to evaluate and monitor the complaint investigation since August 2022. c. The laboratory director confirmed on May 12, 2023 at 10:00 AM that the laboratory failed to evaluate and monitor the patient confidentiality and complaint investigation in the General Laboratory system in the year 2022. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. 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 -- This STANDARD is not met as evidenced by: Based on Quality Assessment records review (QA) and laboratory director interview on May 12, 2023 at 10:00 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following requirements for postanalytic systems: accuracy of calculated data. The findings include: 1. On May 12, 2023 at 9:50 AM; the Quality Assessment records showed that the evaluations of the laboratory calculated data for hematology and chemistry must be performed twice a year. 2. The laboratory did not evaluate the accuracy of calculated data since February 22, 2022. 3. The laboratory director confirmed on May 12, 2023 at 10:00AM, that the laboratory did not evaluate the accuracy of calculated data since February 22, 2022 D6094 LABORATORY DIRECTOR RESPONSIBILITIES 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 Assesstment (QA) records reviewed and laboatory director interview on May 12, 2023 at 10:00 AM; it was determined that the laboratory director failed to ensure the compliance with QA requirements. Refer to D5291 and D5891. -- 2 of 2 --