Laboratorio Clinico Vivianette

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 hematology quality control records ( 2019-2020 ) and interview with the laboratory supervisor on Octuber 6, 2020 at 11:00 A.M.,it was determined that the laboratory failed to ensure compliance with the analytic system requirements for hematology. The findings include: 1. The laboratory failed to follow the manufacturer's instructions for calculating INR (International Normalized Ratio). Refer to D5401. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of hematology records ( 2019-2020 ) and laboratory general supervisor interview on October 6, 2020 at 11:000 a.m. , it was determined that the laboratory failed to follow the manufacturer's instructions for calculating INR (International Normalized Ratio). The findings include: 1. . The laboratory perform PT ( Prothrombin time ) and PTT ( Partial thromboplastin time) tests by Coatron M2 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 -- system. 2. The laboratory had in routine use on October 6, 2020 the following thromboplastin reagent: Lot. # 853668, exp. 9/30/2022. 3. Hematology records were reviewed since January 2020. The records showed that the laboratory did not document nor establish a normal population prothrombin (PT) mean for the thromboplastin new lot number began to use on January 22, 2020. 4. The laboratory processed and reported seventy one (71) patient's samples since January 22, 2020 with the incorrect INR. The laboratory uses the former laboratory PT mean of 11.9 secs. 5. The laboratory general supervisor confirmed on October 6, 2020 at 11:30 A.M. , that the laboratory failed to follow the manufacturer's instructions for calculating INR (International Normalized Ratio). 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 hematology quality control records review ( 2019-2020) and interview with the laboratory general supervisor on October 6, 2020 at 11:00 A.M., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory analytical system requirements for hematology. The finding includes: 1. The laboratory director failed to ensure compliance with the hematology requirements. Refer to D6093. 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 hematology quality control records ( 2019-2020 ) and interview with the laboratory supervisor on Octuber 6, 2020 at 11:00 A.M.,it was determined that the laboratory director failed to ensure compliance with the analytic system requirements for hematology. The findings include: 1. The laboratory failed to follow the manufacturer's instructions for calculating INR (International Normalized Ratio). Refer to D5401. 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 quality control records review ( 2019-2020 ) and laboratory general supervisor interview on October 6, 2020 at 11:00 AM, it was determined that -- 2 of 3 -- the general supervisor failed to follow quality control procedures for hematology. The finding includes: 1. The laboratory failed to follow the manufacturer's instructions for calculating INR (International Normalized Ratio). Refer to D5401. -- 3 of 3 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the laboratory Quality Assessment (Q.A.) Program and interview with the technical supervisor on May 8, 2018, it was found that the laboratory did not follow the established policy regarding the evaluation of the final test report. The findings include: a. The QA Program was reviewed on May 8, 2018 at 11:45 AM. b. The QA Program established that evaluation to the laboratory final test report must be done every year. c. The laboratory did not evaluate the final test report since year 2016. d. The laboratory technical supervisor stated on May 8, 2018 that the evaluations were not performed since year 2016. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on testing personnel records review and technical supervisor interview on May 8, 2018, it was found that the laboratory director did not make sure that the testing 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 -- personnel # 3292, had the necessary training before beginning to perform patient tests. The findings include: a. The testing personnel # 3292 was hired and performed patient testing since January 2018. b. The laboratory did not have any document related to testing personnel training. c. The laboratory technical supervisor stated on May 8, 2018 at 9:30 AM that the laboratory did not document the testing personnel training prior to perform patient tests. 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 competence records and interview with the technical supervisor on May 8, 2018 , it was determined that the laboratory director did not establish procedures for the competence evaluation of the laboratory technical supervisor. The findings include: a. The laboratory director designated as technical supervisor (TS) the medical technologist # 3039. b. The personnel competence since year 2016 files were reviewed on May 8, 2018 at 9:00 AM, however no competence were found for the TS # 3039. c. The TS # 3039 stated that the laboratory director did not established competence procedures for the technical supervisor position. -- 2 of 2 --