American Toxicology

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the on-site complaint investigation (June 24, 2025 - June 26, 2025) and off-site document review (July 1, 2025 - August 6, 2025) conducted with your facility, American Toxicology Institute (29D2079031). The investigation was in response to allegations of: -Failure to perform and evaluate proficiency testing as required - substantiated -Failure to adequately validate screening and confirmatory testing methods - substantiated - Failure to perform and document instrument maintenance - unsubstantiated -Failure to perform quality controls correctly - substantiated -Failure to ensure that quality assessment was performed - substantiated -Failure to comply with safety regulations - substantiated and referred to appropriate authorities The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiency cited herein, the Condition: General Laboratory Systems was not met. The laboratory failed to: -ensure that policies for assessing personnel competency were followed (refer to D5209) -evaluate Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 37 -- the inaccurate proficiency testing results obtained from both internal and external events, and perform

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on March 6, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiency cited herein, the Condition: General Laboratory Systems was not met. The laboratory failed to obtain acceptable twice per year verification of accuracy results for high complexity toxicology for 2022 and 2023, the laboratory failed to evaluate the inaccurate results obtained and perform

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on April 7, 2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) proficiency testing (PT) original evaluations for the 2021 Ethanol Biomarkers (ETB) events A and B, and an interview with the technical supervisor and the laboratory director, the laboratory failed to evaluate the laboratory results obtained using the participant summary for those results not reported to CAP because they exceeded the analytical range for the tests or no credit was given due to the lack of a response. Findings include: 1. There was no documentation of a review of the participant summary for the 2021 Ethanol Biomarkers (ETB) test event A for the ethyl glucaronide immunoassay quantitative results for specimen numbers ETB-01 and ETB-03, and for the ethyl glucaronide and ethyl sulfate LCMS/MS quantitative results for specimen number ETB-01. The laboratory did not report the immunoassay ethyl glucaronide results for specimens ETB-01 and ETB-03 because the results obtained exceeded the analytical range for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- the test. The laboratory did not report the ethyl glucaronide and ethyl sulfate results for specimen ETB-01 because the laboratory indicated that quantitation would not be appropriate for those analytes as they were absent from the specimen. 2. There was no documentation of a review of the participant summary for the 2021 Ethanol Biomarkers (ETB) test event B for the ethyl glucaronide immunoassay quantitative results for specimen numbers ETB-05 and ETB-06, and for the ethyl glucaronide and ethyl sulfate LCMS/MS quantitative results for specimen number ETB-06. The laboratory did not report the immunoassay ethyl glucaronide results for specimens ETB-05 and ETB-06 because the results obtained exceeded the analytical range for the test. The laboratory did not report the ethyl sulfate result for specimen ETB-06 because the laboratory indicated that quantitation would not be appropriate for those analytes as they were absent from the specimen. The laboratory did not submit a result for the LCMS/MS ethyl glucaronide test, and received no credit due to lack of a response. 3. The findings were confirmed during an inteview with the technical supervisor and the laboratory director conducted on April 7, 2022 at approximately 1: 00 PM. The laboratory performs approximately 1,277,200 toxicology tests annually. 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 a review of the 2020 and 2021 laboratory records for the comparison of results for tests performed on more than one instrument and an interview with the laboratory director and the technical supervisor, the laboratory failed to ensure that comparison of the results for the urine drug screen tests, the urine adulterant tests, and the urine drug confirmatory tests performed on multiple instruments was performed twice a year. Findings include: 1. A review of the instrument comparison records for 2020 and 2021 revealed that the laboratory failed to perform the instrument comparisons for the urine drug screen and urine adulterant testing twice a year on the Abbott Architect chemistry analyzers. The laboratory performed the comparisons one time in 2020. The laboratory failed to perform the comparisons in 2021. 2. A review of the instrument comparison records for 2020 and 2021 revealed that the laboratory failed to perform the instrument comparisons for the urine drug confirmation testing twice a year on the AB Sciex LC-MS/MS analyzers. The laboratory performed the comparisons one time in 2020. The laboratory failed to perform the comparisons in 2021. 3. The findings were confirmed during an interview conducted on April 7, 2022 at approximately 1:00 PM with the laboratory director and the technical consultant. The laboratory performs approximately 1,277,200 toxicology tests annually. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) -- 2 of 4 -- Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of the laboratory test report and an interview with the laboratory director and the technical consultant, the laboratory failed to ensure that the address of the laboratory was correct on the final report. Findings include: 1. A review of the laboratory report revealed that the address listed on the laboratory final report was not correct. The laboratory address listed on the report neglected to include both Suite 104 and 105, as designated on the laboratory CLIA certificate. 2. The finding was confirmed during an interview with the laboratory director and the technical consultant during an interview conducted on April 7, 2022 at approximately 3:45 PM. The laboratory performs approximately 1,277,200 toxicology tests annually. 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 a review of the laboratory training and competency assessment records, a review of the director approved policy and procedure, a review of the completed CMS- 209 form, and an interview with the laboratory director and the technical supervisor, the director failed to ensure that initial training and competency assessment for the Abbott Architect chemistry analyzer was completed prior to the performance of testing for testing personnel number six listed on the CMS-209 form. Findings include: 1. A review of the laboratory training and competency assessment records revealed that there was no documentation of initial training and competency assessment for testing personnel number six listed on the CMS-209 form prior to the performance of laboratory testing for urine adulterants, and urine drug screens on the Abbott Architect chemistry analyzer. 2. The director approved policy and procedure entitled, "Training and Competency Testing," in the section entitled, "Training" stated, "New laboratory workers should be trained when first hired on the procedures they will be performing in the laboratory." 3. The findings were confirmed during an interview conducted on April 7, 2022 at approximately 10:30 AM with the laboratory director and the technical supervisor. The laboratory performs approximately 1,277,200 toxicology tests annually. D6116 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(3) The technical supervisor is responsible for enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) 2020, and 2021 urine toxicology proficiency testing (PT) records, a review of the CAP 2022 Proficiency Testing catalog, a review of the laboratory 2022 CAP Proficiency Testing enrollment confirmation and an interview with the technical supervisor and the laboratory director, the technical supervisor failed to ensure that the laboratory enrolled in the proficiency testing program intended for the quantitative urine drug screen confirmation testing by liquid chromatography-mass spectrometry (LC-MS /MS). Findings include: 1. A review of the CAP proficiency testing records for 2020 urine toxicology events one, two and three, a review of the 2021 urine toxicology events one, two and three revealed that the evaluation of the submitted results were for qualitative urine drug screen testing. The laboratory performs quantitative confirmatory testing by LC-MS/MS for urine drug screens. 2. A review of the laboratory's 2022 CAP proficiency testing enrollment revealed that the laboratory was enrolled in the Urine Toxicology (UT) PT program. 3. A review of the CAP 2022 Proficiency Testing catalog revealed that the Urine Toxicology proficiency testing program that the laboratory was enrolled in was not intended for quantitative confirmation of urine drug screen results. The catalog stated that the Urine Toxicology proficiency testing program was intended for "Screening and/or confirmatory drug analysis WITHOUT quantitation (no quantitation)." 4. The findings were confirmed by the technical supervisor and laboratory director during an interview conducted on April 7, 2022 at approximately 10:00 AM. The laboratory performs approximately 1,277,200 toxicology tests annually. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the director approved policy and procedure entitled, "Training and Competency Testing," a review of the laboratory CMS-209 form, a review of the laboratory training and competency assessment records, and an interview with the technical supervisor and the laboratory director, the technical supervisor failed to ensure that new personnel underwent semi-annual training and competency assessment during the first year of testing specimens. Findings include: 1. There was no documentation of the semi-annual training and competency assessment for testing personnel number five listed on CMS-209 form in the performance of the urine drug screen testing and the urine adulterant testing on the Abbott Architect chemistry analyzer. 2. The director approved policy and procedure entitled, "Training and Competency Testing" stated in the section entitled, "Training" in step five, the policy and procedure states, "For new employees, this training is to be repeated after six months and annually thereafter." 3. The technical supervisor stated that the testing person was not a new employee, but had moved into the testing personnel position after obtaining the education and certification to qualify for that position. The finding that the semi-annual training was not completed was confirmed during an interview with the technical supervisor and the laboratory director conducted on April 7, 2022 at approximately 10:30 AM. The laboratory performs approximately 1,277,200 toxicology tests annually. -- 4 of 4 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on November 19, 2019. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a random audit of patient chemistry and toxicology requisitions and patient final reports from 1/17/18 through 10/29/19 and an interview with the laboratory manager, the laboratory failed to follow policies and procedures to ensure positive identification of patients's specimens from the time of collection through the completion of the testing and the reporting of the results. Findings include: A random audit of ten patient requisitions and the associated final test reports from 1/17/18 through 10/29/19 revealed one of ten patient requisitions with a collection date of 1/04 /18, indicated a date of birth (DOB) of 2/9/1979 on the requisition and a DOB of 2/9 /1974 on the patient final report. This was confirmed by the laboratory manager on November 19, 2019 at approximately 3:30 PM. The laboratory performs approximately 1,277,200 Chemistry and Toxicology tests annually. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the proficiency testing records for Chemistry and Toxicology for testing years 2018 and 2019 and an interview with the laboratory manager, the laboratory failed to, at least twice annually, verify the accuracy of all non-waived, non- regulated analytes in which the laboratory performs. Findings include: 1. The laboratory failed two of two events in testing year 2018 for Ethyl Glucuronide quantitative, Ethyl Glucuronide qualitative and Ethyl Sulfate. 2. There were no subsequent proficiency testing (PT) samples acquired from an accredited PT agency or other methods used to determine, at least twice annually, the verification of the accuracy of these three analytes for testing year 2018. This was confirmed by the laboratory manager on November 19, 2019 at approximately 1:30 PM. The laboratory performs approximately 1,277,200 Chemistry and Toxicology tests annually. 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 a random audit of Chemistry and Toxicology quality control performed from 1/17/18 through 10/29/19 and an interview with the laboratory manager, the laboratory failed to follow the director approved policy and procedure manual which states that both levels of quality control must be acceptable before patient test reports may be released. Findings include: 1. The laboratory failed to follow the director approved policy for quality control which states that both levels of quality control must be within the established acceptable range before patient results can be released. 2. A random audit of quality control performed from 1/17/18 through 10/29/19 found on 1/17/18, the quality control performed for PCP was outside of the acceptable range for PCP 1 and was within the acceptable range for PCP 2. There was no additional quality control performed on that date for PCP 1. 3. There was 1 of 90 patient Toxicology tests that were reported on 1/17/18 with a positive PCP. This was confirmed by the laboratory manager on November 19, 2019 at approximately 3:30 PM. The laboratory performs approximately 1,277,200 Chemistry and Toxicology tests annually. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the director approved policy and procedure manual and an interview with the laboratory manager, the laboratory director failed to establish and maintain a quality assessment program to assure the quality of the laboratory services provided and identify failures in quality as it occurs. Findings include: 1. The laboratory director failed to have a policy established to assess the quality of the laboratory services provided on a regular basis for the pre-analytic, the analytic and the post-analytic phases of laboratory testing. 2. There was no documentation of quality assessment being performed for testing years 2018 and 2019. This was confirmed by the laboratory manager on November 19, 2019 at approximately 3:00 PM. The laboratory performs approximately 1,277,200 Chemistry and Toxicology tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA complaint investigation survey conducted at your facility on May 8, 2018 and a telephone conversation on May 10, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a review of patient toxicology screening tests performed on March 17, 2018 and on March 19, 2018 and an interview with the lead laboratory technician, the laboratory failed to ensure positive identification of a patient specimen from the time of collection through the completion of testing and reporting of the results. Findings include: 1. The laboratory failed to properly identify a patient specimen during the analytic phase of patient toxicology testing which resulted in the reporting of incorrect results which had a direct effect on patient care. 2. Patient A with a specimen labeled with the accession number 1086Y was found to be positive for marijuana at a high level that required the specimen to be diluted and repeated. The specimen 1086Y was diluted and repeated but the technician that performed the test on the specimen incorrectly entered into the toxicology instrument, the accession number from Patient B which was 1096Y. The specimen number 1096Y initially was found to be negative for marijuana from the toxicology screening test but the final report for Patient B with 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 -- accession number 1096Y was incorrectly reported as positive for marijuana due to the accession number entry error. 3. The provider for the patient 1096Y questioned the results from the laboratory. An internal investigation by the laboratory found the technician's error and the laboratory generated a corrected report to the provider. This was confirmed by the lead laboratory technician on May 8, 2018 at approximately 10: 00 AM. The laboratory performs approximately 150,000 patient chemistry and toxicology tests annually. D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on a review of the State of Nevada regulations regarding the qualifications for testing personnel performing high complexity testing, a review of the testing personnel State of Nevada laboratory licenses and an interview with the lead technician of the laboratory, the laboratory failed to ensure that all personnel performing high complexity testing meet the qualifications for performing high complexity tests and possessed a current State of Nevada laboratory license which met the qualifications for the performance of high complexity testing. Findings include: 1. The laboratory failed to ensure that one of three laboratory testing personnel performing high complexity testing meet the qualifications and had the correct laboratory licensure for the performance of high complexity testing. 2. There was one of three laboratory testing personnel which had a State of Nevada Specialty Technician in Chemistry license which allows the technician to perform moderate complexity testing and to read test results directly from the instrument with no interpretation and no intervention during the analytic phase of testing. 3. The Specialty Technician in Chemistry was found to be performing high complexity toxicology testing using the LCMS toxicology instrument which requires intervention and interpretation during the analytic phase of testing. This was confirmed by the lead laboratory technician on May 8, 2018 at approximately 10:00 AM. The laboratory performs approximately 150,000 patient chemistry and toxicology tests annually. -- 2 of 2 --