Forensic Fluids Laboratories Inc

Summary Statement of Deficiencies D0000 An unannounced complaint investigation was completed on November 13, 2024 at Forensic Fluids Laboratories, Inc by the State of Michigan Licensing and Regulatory Affairs Department. During the investigation, it was determined the laboratory was out of compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003). 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 record review and interview with the Laboratory Director, the laboratory failed to follow its procedures for fentanyl analysis and reporting for one (Patient #1) of five patient test records reviewed. Findings include: 1. A review of the laboratory's "Drug Specific Guidelines" revealed a section titled "Fentanyl (FENT)" stating, " If FENT screen is positive and confirmation is 0.5 -0.9 ng/mL, submit an UF for Fentanyl Trace. Do not report this value in LIMS" and the cutoff values for screening and confirmation were "1.0 ng/mL." 2. A review of Patient #1's test report with oral fluid toxicology testing performed and reported on 8/27/24 revealed the result of "Negative" for fentanyl. 3. A review of the analytical data from the run with Patient #1's sample revealed the specimen was negative for the drug screen the laboratory received a result of "0.928" for fentanyl concentration during confirmation testing. 4. A review of the laboratory's Salesforce program for documenting calls to clients revealed a call to client ordering the testing for Patient #1 was notified of "trace Fent" on 8/28/24. 5. An interview on 11/13/24 at 2:28 pm with the Laboratory Director confirmed calling results obtained below the cutoff values had been a practice of the laboratory. 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 -- D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor, the laboratory failed to ensure patient names were accurately entered on test reports for one (Patient #2) of five patient test records reviewed. Findings include: 1. A review of the test request and test report for Patient #2 receiving testing on 8/22/24 revealed a discrepancy in patient last name. 2. An interview on 11/13/24 at 2:56 pm with the General Supervisor confirmed the name on Patient #2's test report was inaccurately entered. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 lack of documentation and interview with the Technical Supervisor (TS), the laboratory failed to verify the accuracy of its toxicology testing at least twice annually for 19 (January 2022 to August 2023) of 19 months of testing. Findings include: 1. A review of the laboratory's records revealed a lack of verification of accuracy for 19 months for its toxicology testing on the following analytes: a. Depakote b. Disulfiram c. Ethyl Glucuronide (EtG) d. Ethyl Sulfate (EtS) 2. An interview on 8/29/2023 at 2:00 pm, the TS confirmed the laboratory had not performed verification of accuracy testing for the analytes listed above from January 2022 to August 2023. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 record review and interview with the Laboratory Director (LD), the laboratory failed to report all SARS-CoV-2 test results every day of patient testing for 3 (October 2021 to January 2022) of 3 months the laboratory has been testing for SARS-CoV-2. Findings include: 1. The surveyor observed the laboratory's Orasure SARS-CoV-2 Antibody ELISA test system on 1/19/22 at 10:36 am. 2. An interview on 1/19/22 at 10:36 am with the LD revealed the laboratory started testing in October 2021 and had not been reporting results to the health department. 3. A review of the laboratory's test records revealed 30 patients had been tested using the Orasure SARS- CoV-2 Antibody ELISA test system and had not been reported to the health department. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 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 -- 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to ensure personnel performing highly complex testing met the testing personnel qualification requirements of 493.1489. Findings include: 1. The laboratory failed to ensure personnel performing high complexity testing were qualified as testing personnel. Refer to D6171. ***This is a repeated Condition-Level deficiency from the 11/25/19 recertification survey*** D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality -- 2 of 3 -- control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on record review and interviews with the Laboratory Director, the laboratory failed to ensure personnel performing high complexity testing were qualified as testing personnel for 1 (Immunalysis Direct ELISA Kit oral fluid toxicology screening) of 2 high complexity test systems used by the laboratory. Findings include: 1. A review of the laboratory's "Immunalysis Direct ELISA Kit" package insert and test menu revealed the oral fluid toxicology screening testing performed by the laboratory was categorized as high complexity. 2. A review of the laboratory's "Standard Operating Procedure Title: Oral Fluid ELISA Screening" revealed a section titled, "Washing and Drying ELISA Plates" noting the process to perform plate washing within the test procedure. 3. An interview on 1/19/22 at 3:19 pm with the Laboratory Director revealed staff from other departments will help the laboratory when they are busy by washing ELISA plates. The Laboratory Director confirmed the staff from other departments were not qualified as high complexity testing personnel. ***This is a repeated Standard-Level deficiency from the 11/25/19 recertification survey*** -- 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 record review and interview with the Laboratory Director (LD), the laboratory failed to report all SARS-CoV-2 test results every day of patient testing for 3 (October 2021 to January 2022) of 3 months the laboratory has been testing for SARS-CoV-2. Findings include: 1. The surveyor observed the laboratory's Orasure SARS-CoV-2 Antibody ELISA test system on 1/19/22 at 10:36 am. 2. An interview on 1/19/22 at 10:36 am with the LD revealed the laboratory started testing in October 2021 and had not been reporting results to the health department. 3. A review of the laboratory's test records revealed 30 patients had been tested using the Orasure SARS- CoV-2 Antibody ELISA test system and had not been reported to the health department. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 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 -- 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to ensure personnel performing highly complex testing met the testing personnel qualification requirements of 493.1489. Findings include: 1. The laboratory failed to ensure personnel performing high complexity testing were qualified as testing personnel. Refer to D6171. ***This is a repeated Condition-Level deficiency from the 11/25/19 recertification survey*** D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality -- 2 of 3 -- control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on record review and interviews with the Laboratory Director, the laboratory failed to ensure personnel performing high complexity testing were qualified as testing personnel for 1 (Immunalysis Direct ELISA Kit oral fluid toxicology screening) of 2 high complexity test systems used by the laboratory. Findings include: 1. A review of the laboratory's "Immunalysis Direct ELISA Kit" package insert and test menu revealed the oral fluid toxicology screening testing performed by the laboratory was categorized as high complexity. 2. A review of the laboratory's "Standard Operating Procedure Title: Oral Fluid ELISA Screening" revealed a section titled, "Washing and Drying ELISA Plates" noting the process to perform plate washing within the test procedure. 3. An interview on 1/19/22 at 3:19 pm with the Laboratory Director revealed staff from other departments will help the laboratory when they are busy by washing ELISA plates. The Laboratory Director confirmed the staff from other departments were not qualified as high complexity testing personnel. ***This is a repeated Standard-Level deficiency from the 11/25/19 recertification survey*** -- 3 of 3 --

Summary Statement of Deficiencies D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, 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 record review and interview, the laboratory failed to meet the requirements for the specialty in Toxicology as specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to verify the accuracy of testing for the toxicology testing. Refer to D5217. 2. The laboratory failed to enter test requisitions accurately. Refer to D5309. 3. The laboratory failed to establish and verify the performance specifications for 3 (MS14, MS15, and MS16) Micromass Mass Spectrometer analyzers and for 7 drugs in use and on the "Forensic Fluids Laboratories Testable Drugs" chart. Refer to D5423. 4. The laboratory failed to perform and document the annual preventive maintenance (PM) for 14 (MS2 - MS15) of 15 Micromass Mass Spectrometers instruments. Refer to D5429. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 record review and interview with the Laboratory Director (LD) and Data Analyst (DA), the laboratory failed to verify the accuracy of testing for the toxicology testing for 2 (2018 and 2019) of 2 years at least twice annually. Findings include: 1. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Record review for the verification of accuracy for the toxicology testing revealed there was no documentation to show the testing was completed at least twice annually in 2018 and 2019 for the following parent and/or metabolite analytes as follows: a. Therapeutic drugs 1. Valproic Acid b. DRUG 1. Disulfiram 2. Ethyl Glucuronide (EtG) 3. Ethyl Sulfate (EtS) 4. Gamma Hydroxybutyric Acid 5. Methaqualone 6. Salvinorin A 2. During the phone interview on 12/02/19 at approximately 10:18 am, the LD acknowledged bi-annual verification of accuracy was not performed and documented for all tests. During the phone interview on 12/03/19 at approximately 3: 17 pm, the DA confirmed the above tests did not have bi-annual verification of accuracy performed and documented. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: . Based on record review and interview via a phone call with the Laboratory Director (LD), the laboratory failed to enter test requisitions accurately for 3 (#4, #5, and #8) of 9 patient testing reviewed. Findings include: 1. Record review of patient (#4, #5, and #8) test requisitions and final reports from December 2017 to September 2019 revealed the following discrepancies: Patient #4 a. The tests indicated on the requisition and not signed by the ordering physician on 9/13/18 revealed the following tests ordered: Amphetamine, Methamphetamine, THC, Cocaine, Opiates, Benzodiazepine, Barbiturates, Methadone, Oxycodone, Buprenorphine, Tramadol, K2, and Fentanyl. c. The final report included the following tests not indicated on the requisition: Norbuprenorphine Patient #5 a. The tests indicated on the requisition and not signed by the ordering physician on 11/30/18 revealed the following tests ordered: Amphetamine, Methamphetamine, THC, Cocaine, Opiates, Benzodiazepine, Barbiturates, Methadone, Oxycodone, Buprenorphine, Tramadol, K2, and Fentanyl. b. The final report included the following tests not indicated on the requisition: Benzoylecgonine (BZE) and Ecgonine Methyl Ester (EME) Patient #8 a. The tests indicated on the requisition and not signed by the ordering physician on 6/27/19 revealed the following tests ordered: Amphetamine, Methamphetamine, THC, Cocaine, Opiates, Benzodiazepine, Methadone, Oxycodone, Buprenorphine, Fentanyl, and Alcohol. b. The final report included the following tests not indicated on the requisition: Alprazolam (Xanax), Bromazepam, Chlordiazepoxide, Clonazepam (Klonopin), 7-aminoclonazepam, Diazepam, Nordiazepam, Estazolam, Flunitrazepam, Flurazepam, Lorazepam (Ativan), Lormetazepam, Midazolam, Nitrazepam, Oxazepam, Prazepam, and Temazepam. 2. During the interview via a phone call on 12/02/19 at approximately 10:18 am, the LD acknowledged the test requisitions did not contain the names of the confirmatory testing (metabolites) completed with a positive screening result. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test -- 2 of 5 -- system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: . A Based on record review and interview with the Laboratory Director (LD), the laboratory failed to establish and verify the performance specifications for 3 (MS14, MS15, and MS16) of 15 Micromass Mass Spectrometer analyzers for each toxicology analyte/metabolite for 23 (1/22/18 to 1/21/19) of 24 months of operation. Findings include: 1. Record review of the "Validation Book" revealed for MS14, MS15, and MS16 Micromass Mass Spectrometer the only analyte or metabolite documented was 6-MAM. 2. Lack of documentation for accuracy, precision, analytic specificity, analytic sensitivity, and interfering substances was not available on the day of the survey for all the toxicology testing. 3. During the interview on 11/25/19 at 2:30 pm, the LD acknowledged the validation studies for the 3 Micromass Mass Spectrometers lacked full documentation of the performance specifications. B . Based on record review and interview with the Laboratory Director (LD) and the Data Analysts (DA), the laboratory failed to establish and verify the performance specifications for 2 (November 2018 to November 2019) of 2 years reviewed. Findings include: 1. Record review of the "Validation Book" revealed a lack of documentation for 2 of 2 years for the following analytes/metabolites listed on the "Forensic Fluids Laboratories Testable Drugs (PT=Proficiency, BI=Biannual)" chart as follows: a. Valproic Acid b. Disulfiram c. Ethyl Glucuronide (EtG) d. Ethyl Sulfate (EtS) e. Gamma Hydroxybutyric Acid f. Methaqualone g. Salvinorin A 2. During the phone interview on 12/03/19 at approximately 3:17 pm, DA acknowledged the tests had only been run since 11/2019 for a portion of the tests expect Salvinorin A which had been run since 3 /2018. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory failed to perform and document the annual preventive maintenance (PM) for 14 (MS2 - MS15) of 15 Micromass Mass Spectrometers instruments in 2018 and /or 2019. Findings include: 1. Record review for each Micromass Mass Spectrometer instrument revealed a lack of documentation for the annual PM performed by the company "Waters" as follows: a. MS2 - due 8/2019 b. MS3 - due 7/2019 c. MS4- due 7/2019 d. MS5 - due 8/2019 e. MS6 - due 4/2018 and 4/2019 f. MS7 - due 2/2019 g. MS8 - due 6/2019 h. MS9 - due 7/2019 i. MS10 - due 8/2019 j. MS11 - due 11/2018 and 11/2019 k. MS12 - due 8/2019 l. MS13- due 7/2019 m. MS14 - 1/2019 n. MS15 - 1/2019 2. During the interview on 11/25/19 at approximately 3:07 pm, the LD acknowledged the "Waters" preventive maintenance records were not included in the -- 3 of 5 -- maintenance binder for each instrument and that the "Waters" technical service person was on-site on the day of the survey. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on document review, observation, and interview with the Laboratory Director (LD), the laboratory failed to ensure for 1 (Testing Personnel #15 {TP15}) of 21 TP who perform highly complex toxicology testing met the educational requirements at 42 CFR 493.1489. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and -- 4 of 5 -- storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on document review and interview with the Laboratory Director (LD), the laboratory failed to ensure 1 (Testing Personnel #15 {TP15}) of 21 high complexity TP met the educational requirements at 42 CFR 493.1489. Findings include: 1. Record review of TP credentials revealed the educational requirements were not met for 1 (TP15) of 21 testing personnel performing highly complex toxicology testing. 2. During the interview on 11/25/19 at 10:10 am, the LD confirmed TP15 did not meet the educational requirements at CFR 493.1489. 3. The laboratory was given 7 additional days to supply the necessary educational documents. The documents were not received. -- 5 of 5 --