Laboratorio Clinico Bahia

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation of the laboratory physical area and interview with the laboratory general supervisor on October 28, 2021 at 12:15 P.M., it was determined that the laboratory work areas did not have sufficient space in order to ensure the specimen handling and testing. Refer to D 3001. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation and laboratory general interview on October 28, 2021 at 12:00 P. M., it was determined that the laboratory failed to ensure that an adequate space were 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 -- available for handling, examination and testing of patient samples and minimized the contamination of patient specimens in the laboratory area. The findings include: 1. The size of the laboratory area is approximately 8 ' ( length) and 7' ( width). In this space the laboratory have a Cell Dyn 3200 system, Id Now system, Urinalysis system, centrifuge . 2. Over the Cell Dyn 3200 system the laboratory had the printer , monitor with the key board 3. In the area the laboratory also observed four solar battery in the floor. 4. The laboratory general supervisor confirmed on October 28, 2021 at 12:15 P. M. that the testing area were very crowded and letting few space to perform patient samples. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Mycoplasma pneumoniae quality control records patient records review ( 2021 ) and interview with the laboratory supervisor on October 28, 2021 at 11:30 AM, it was determined that the laboratory failed to meet the requirements in the subspecialty of General Immunology. The finding includes: 1. The laboratory did not include an external positive and a negative control material each day of patient testing. Refer to D 5449- The laboratory did not include positive and negative control material. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 1. Based on General Immunology (Mycoplasma pneumoniae test) quality control records review from January 2021 to October 28, 2021 and interview with the laboratory supervisor on October 28, 2021 at 11:30 AM, it was determined that the laboratory did not include an external positive and negative control material each day of Mycoplasma pneumoniae patient testing. The findings include: a. The laboratory begin to perform Mycoplasma pneumoniae by Immuno Card system on January 2021. b. Review of Mycoplasma pneumoniae quality control at patient results record showed that the laboratory did not include any control material each day of testing the following days: date patient number 10/18/21 140662 10/20/21 1407292, 1407332 10 /26/21 1410082,1410132, 1410192 10/27/21 1410802 10/28/21 141095 c. The laboratory supervisor confirmed on October 28, 2021 at 11:30 AM, that the laboratory failed to include a negative and positive control material in these days of testing when performed Mycoplasma pneumonia test. D6076 LABORATORY DIRECTOR -- 2 of 3 -- 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 General Immunology quality control records review ( 2021 ) , physical facilities observaction and laboratory general supervisor interview on October 28, 2021 at 12:15 P.M., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control and physical facilities requirements. Refer to D 6083 and D 6093. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on physical plant observation and interview with the laboratory general supervisor on October 28, 2021 at 12:15 P.M. , it was determined that the laboratory director did ensure that the physical plant (crowded space) were appropriate for specimen testing and handling. Refer to D3001. 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 Mycoplasma pneumonia IgM quality control records and interview with the laboratory general supervisor on October 28,2021 at 11:30 AM, it was determined that the laboratory director failed to ensure compliance with the requirement for analytic systems. Refer to D5449. 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 Mycoplasma pneumonia IgM quality control records and interview with the laboratory general supervisor on October 28,2021 at 11:30 AM, it was determined that the laboratory general supervisor failed to ensure compliance with the requirement for analytic systems. Refer to D5449. -- 3 of 3 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on lack of patient test reports and laboratory general supervisor interview at 11: 00 a.m. on November 5, 2019, it was determined that the laboratory failed to keep copy of the original patient test reports. Refer D3041. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: 1. Based on lack of patient test reports and laboratory general supervisor interview on 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 -- November 5, 2019 at 10:00 A.M., it was determined that the laboratory failed to retain a copy of the original patient test reports. The findings include: a. Patient samples test reports was requested from January 2018 to November 5, 2019. b. The laboratory performed approximately 34 patient samples during those months: Syphiis serology-1 Urinalysis-2 human chorionic hormone ( hCG)-1 complete blood cell count- (CBC) 30 c. The laboratory did not have copy of patient's test reports that was performed during those months. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 lack of Quality Assessment (QA) records ( year 2018-2019) and laboratory general supervisor interview on November 5, 2019 at 10:30 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for pre- analytic systems. The findings include: 1. The laboratory did not evaluate the following QA assessment for pre- analytic systems from January 1, 2018: a. Test requests b. Specimen submission, c. Specimen handling. d. Specimen referral. 2. The laboratory general supervisor confirmed on November 5, 2019 at 10: 30 A.M., that the QA program was not evaluated since January 2018. 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 quality assessment procedures manual, lack of quality assessment records (2018-2019) and laboratory general interview interview on November 5, 2019 at 10: 30 A.M., it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for post-analytic systems. The findings include: 1. Review of the quality assessment program showed that evaluations to patient's final test reports and turn around time ( TAT) must be evaluated every year. 2. The laboratory general supervisor stated on November 5, 2019 at 10:30 A.M. that evaluations to patient's final test reports and turn around time were not performed since 2017. 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on lack of patient test reports and laboratory general supervisor interview at 11: 00 a.m. on November 5, 2019, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory retention requirements. Refer D3041. 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 lack of patient test results and laboratory general supervisor interview at 11: 30 a.m. on November 5, 2019, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory retention requirements. The finding includes: 1. The laboratory failed to retain a copy of the original patient test reports. Refer D3041. -- 3 of 3 --