Genex Labobatories

Summary Statement of Deficiencies D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) Proficiency Testing (PT) records and interview with the laboratory technical supervisor (TS); it was determined that the laboratory failed to attain a score of least 80 percent of acceptable responses for Antistreptolysin O (ASO) for the third event of 2020 (Q3- 2022). The findings included: 1. Based on review of PT records for Q3-2020, API reported an unsatisfactory score of 40% for RA/RF analyte as follow: Sample Result Expected Performance Sample 11 Positive Positive Acceptable Sample 12 Positive Negative Unacceptable Sample 13 Negative Positive Unacceptable Sample 14 Negative Negative Acceptable Sample 15 Positive Positive Acceptable 2. Based on the laboratory's testing declaration at the time of the survey on October 17, 2023, the laboratory reported approximately 8,000 General Immunology tests results which included ASO analyte during the time the laboratory had unsatisfactory PT testing scores. 3. The TS affirmed that the laboratory received the above unsatisfactory General Immunology ASO PT score. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: 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 -- Based on surveyor's review of the laboratory's proficiency testing records and interview with the laboratory technical supervisor on October 17, 2023; it was determined that the laboratory director, failed to ensure that PT samples for General Immunology analyte Antistreptolysin O for the third event of 2022 were tested as required under subpart H. of this part. See D2076 -- 2 of 2 --

Summary Statement of Deficiencies 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Hematology constituting unsuccessful PT performance. (See D2130) 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, WBC DIFF, as follows: 2021 Q3 2022 Q2 WBC DIFF 40% 60% Q2 = Second testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, WBC DIFF.. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, WBC DIFF, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (see D2016 and D2130) -- 2 of 2 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts (AAB) testing records, six (6) random patients sampling, and interview with the testing personnel; it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for anti-HCV on the third event of 2020 (Q3-2020). The findings included: 1. The API proficiency program gave an unsatisfactory score of 40% for anti-HCV on the third event of 2020 (Q3-2020). . 2. Based on the laboratory's annual testing declaration submitted on the day of the survey November 16, 2021, the laboratory analyzed and reported approximately 1,116 anti-HCV, during the time the laboratory had unsatisfactory proficiency testing results. 3. The technical supervisors confirmed on 11/16/2021 at approximately 12:00 p.m. that the laboratory received the above proficiency score of 40% for anti-HCV on the third event of 2020 described in 1. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Assocoation of Bioanalysts (AAB) proficiency testing records and interview with the testing personnel (TP); it was determined that 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 -- the laboratory failed to attain a score of at least 80 percent of acceptable responses for Folate analyte for the third event of 2020 (Q3-2020). The finding included: 1. Based on review of PT records for Q3-2020, AAB reported an unsatisfactory score of 50% for Folate: Folate (ng/ml) Sample # Reported Intended range 11 6.4 3.3 - 6.2 12 2 1.1 - 2.9 2. Based on the laboratory testing declaration submitted at the time of the survey on 11/16/2021 the laboratory analyzed and reported approximately 80,436 routine chemistry tests including Folate during the time the laboratory had unsatisfactory proficiency testing results. 3. The TP affirmed 11/16/2021 at approximately 1:15 p.m. that the laboratory received the above unsatisfactory proficiency testing score. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts (AAB) testing records, six (6) random patients sampling, and interview with the testing personnel; it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Neutrophil cell counts on the second event of 2020 (Q2-2020). The findings included: 1. The API proficiency program gave an unsatisfactory score of 60% for Neutrophil cell count for Q2-2020. 2. Based on the laboratory's annual testing declaration submitted on the day of the survey November 16, 2021, the laboratory analyzed and reported approximately 20,689 complete blood cell counts which included Neutrophil cell counts, during the time the laboratory had unsatisfactory proficiency testing results. 3. The technical supervisors confirmed on 11 /16/2021 at approximately 11:45 a.m. that the laboratory received the above proficiency score of 60% for Neutrophil cell counts described in 1. 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 the lack of laboratory current written policies and procedures and interview with the laboratory personnel, it was determined that the laboratory failed to have available and follow written procedures for SARS-CoV-2 Antibody detection test procedure performed in the laboratory. The findings included: 1. On the day of the survey on November 16, 2021 at approximately 12:30 p.m. the laboratory failed to provide written policies and procedures for SARS-CoV-2 Antibody detection test procedures currently performed in the laboratory. 2. For two (2) out of six (6) random patient test results reviewed covering period from 9/22/2020 to 08/18/2021 the patients had SARS-CoV-2 Antibody detection test ordered, analyzed, and reported for which the laboratory had no written policies and procedures available for the current -- 2 of 3 -- practice. 3. The laboratory staff confirmed on November 16, 2021 at approximately 12:45 p.m. that the laboratory did not have written policies and procedures available for the current SARS-CoV-2 Antibody detection test performed in the laboratory. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's records for policies and procedures, proficiency testing results, lack of delegation of responsibilities, and interview with the technical supervisor and laboratory testing personnel on November 16, 2021; it was determined that the laboratory director failed to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of laboratory testing were monitored. See D2075, D2088, D2121, D5401, and D6107. 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 the laboratory's records of personnel training, competency evaluation, laboratory policies and procedures, random patient testing records, and interview with the laboratory 's testing personnel (TP); the laboratory failed to provide records showing that the laboratory director (LD) has authorized, delegated, and approved lab personnel of any responsibilities and duties in writing. The findings include: 1. The laboratory did not have any records of written delegation and authorization of responsibilities and duties by the LD for laboratory testing personnel. 2. On November 16, 2021 at approximately 2:00 p.m., the TP affirmed that the LD did not assign, delegated, and authorized in writing duties and responsibilities to the laboratory personnel including the technical supervisor and the general supervisor. 3. The laboratory testing declaration form, signed by the LD on November 11, 2021 stated that the laboratory performs 528,743 tests annually. -- 3 of 3 --