Award Information
Description of original award (Fiscal Year 2022, $500,000)
Hamilton County Ohio has been significantly impacted by the fluctuating drug trends seen across the country. Historically, the lab caseload has been hit hard by opiates and synthetic opioids including Fentanyl analogs, but now novel synthetic substances such as synthetic Benzodiazepines and Nitazenes must be considered. The seized drug analysis section at the Hamilton County Coroner’s Office and Crime Lab (HCCO) finds new synthetic drugs in casework and notifies the toxicology section, but adequate instrumentation needed to properly analyze such compounds is not available. When synthetic drugs are expected to be a contributory cause of death in coroner cases, the toxicology section must send the sample to a contract lab for testing, resulting in an increased turnaround time and cost. Currently, the toxicology section is only able to presumptively identify a couple of synthetic drugs outside of Fentanyl analogs. This causes the drugs to not be reported in impaired driving (OVI), assault/drug facilitated crimes (DFC), and other crime lab cases as presumptive results do not get included on the toxicology report. Furthermore, the presence of these drugs is likely often missed because the toxicology lab does not currently have the capability to detect a majority of them at all. Routine toxicology caseload is also high and many of these poly-drug cases require longer testing periods. Faster methods can be built on new instrumentation to combat this. Overall, new instrumentation will enable the toxicology section to identify and quantitate a wider range of licit and illicit drugs in a reduced amount of time, increasing throughput and decreasing turnaround time.
The toxicology section analyzes biological matrices for the presence and concentration of drugs and alcohol for both post-mortem and ante-mortem crime lab cases. Post-mortem cases are either brought up from the in-house morgue or transported to the morgue from one of the out-of-county coroners we serve. There are about forty-five Hamilton County and thirty out-of-county police agencies who submit crime lab cases for toxicological analysis as well. Figure 1 demonstrates the caseload for both coroner and crime lab cases requiring toxicological analysis.
Although crime lab cases did see a decrease in 2021, coroner cases tend to steadily rise year-to year. Statistics for 2020 and 2021 could be skewed by decreased travel due to COVID-19 closures. Violent crime in the form of homicide and DFC/sexual assault has also increased over the past four years, although there was a decreased number of reported DFC cases in 2021. Instrumentation must be sufficient enough to allow the toxicology section to not only keep up with these increasing numbers, but to also stay ahead of drug trends and increasing demand caused by poly-drug use.
With the use of Coverdell grant funds from 2020 the toxicology laboratory was able to significantly decrease turnaround time by obtaining updated instrumentation. Figure 2 shows current and historical turnaround time and backlog statistics for the forensic toxicology section. There were a couple of setbacks during the grant period, both COVID-related and not, that caused brief increases in turnaround time, but the grant period is still active and turnaround time is currently down to 23 days from the 35 days reported in Figure 2. The current total backlog is 142 cases, down from 313 at the end of 2021. Advances in both drug synthesis and trends demand more sensitive instrumentation to maintain the achieved turnaround time. The Gas Chromatography/Mass Spectrometry (GC/MS) instruments purchased with previous grant funds are used daily and help tackle the Opioid and Fentanyl analog cases, but are not capable of seeing the newer synthetic drugs. The high number of backlogged toxicology cases demonstrates a substantial need for improvement in the section’s analytical strategies and efficiency. The Hamilton County Coroner, as well as the pathologists served by the toxicologists’ work, have requested a 20-day turnaround time, and currently this is not being satisfied. This is a compounding issue with the fact that new synthetic drugs are being completely missed. The accrediting body for our medical examiners’ services, National Association of Medical Examiners (NAME), also has turnaround time requirements that must be met to uphold accreditation. Above all, the longer it takes to complete toxicological testing, the longer grieving families must wait before a death certificate is issued and they are provided with answers. Similarly, criminal trials to sentence impaired drivers are also delayed awaiting toxicology results.
Figure 1: Toxicology Caseload
2018
2019
2020
2021
Total Toxicology Coroner Cases
1,547
1,407
1,526
1,663
Total Toxicology Homicide Cases
88
103
121
131
Total Toxicology OVI Cases
586
667
720
593
Total Toxicology DFC Cases
106
96
104
79
Total Toxicology Cases
2,239
2,170
2,350
2,335
Figure 2: Toxicology Turnaround Time and Backlog Data
2018
2019
2020
2021
Coroner Case turnaround time at the end of each year (days)
37.5
34.3
30.3
35.3
Crime Lab Case turnaround time at the end of each year (days)
Not available
50.6
43.2
57.8
Coroner Case backlog data at the end of each year (cases)
167
182
115
197
Crime Lab Case backlog data at the end of each year (cases)
Not available
105
115
116
The Opioid epidemic is still a significant issue in Hamilton County, but now it has expanded to include other synthetic drugs. The number of Opioid and synthetic drug-related cases worked by the HCCO toxicology section is revealed in Figure 3. The Opioid drug class includes all Opiates such as the Heroin metabolite, 6-Monoacetylmorphine (6-MAM) and Fentanyl and its analogs. The statistics in Figure 3 also include the limited number of synthetic benzodiazepines we are capable of seeing. This is likely a poor reflection of the prevalence of such drugs in Hamilton County. As proven by the statistics, opioids and synthetic drugs contribute to about 90% of the overdose cases, and have been a high percentage of the case work at least since 2018. The seized drug analysis section at HCCO saw nearly 300 items containing novel psychoactive substances (NPS), which includes Nitazenes, PCP analogs, and Synthetic Cannabinoids. In addition, the drug section also saw nearly 700 items containing Schedule I benzodiazepines, which include several synthetics. Qualitative presumptive screening of all drugs is performed by Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS). All drugs are currently extracted in-house and quantitated by GC/MS or LC-MS/MS. This federal assistance will allow the toxicology section to purchase a new GC/MS system and a new LC-MS/MS system. The toxicology section currently has four GC/MS systems completely up and running, one of which is approaching 10 years old. The instrument that was over 10 years old went out of service while awaiting availability of grant funds. If the older instrument goes down for maintenance needs, productivity becomes compromised. Even routine in-house cleaning and maintenance takes the instrument out of operation for a day. Warranties on these older instruments are also void and at any time they could stop operating properly. Newly developed GC/MS systems allow for increased sensitivity to detect trace concentrations of drugs extracted from biological matrices. The HCCO forensic toxicology section has two LC-MS/MS systems, but only one fully capable of running the presumptive screen that is run on nearly every case. This presumptive screen is used to initially identify a range of drugs to include Opiates, Fentanyl analogs, and synthetic Benzodiazepines. New drugs have arisen with increasing potencies, making it vital to be able to detect sub-nanogram concentrations with accuracy and reproducibility. The section currently sends some cases to outside labs for toxicological analysis when concentrations are too low to accurately quantitate in-house or when drugs are present outside the lab’s testing capabilities. This results in an increase in testing costs as well as turnaround time, as there is down time associated with the transportation of samples. Having only one LC-MS/MS capable of screening causes an issue with instrument availability and therefore turnaround time. An increase in advanced instrumentation will allow the toxicology section to analyze and quantitate a wider range of drugs in an efficient and timely manner.
Figure 3: Opioid Toxicology Coroner Caseload
2018
2019
2020
2021
Total Overdose Cases
468
413
424
442
Opioid Related Overdoses
426
380
382
402
% of Opioid Related Overdoses
91.0%
92.0%
90.0%
90.9%
The toxicology section cannot continue to keep up with dynamic drug trends associated with the opioid and synthetic epidemic or decrease backlog and turnaround time unless new instrumentation is acquired. The laboratory would be crippled if these vital instruments became unusable and unable to be repaired in a timely fashion. The instruments requested using grant funds come with a three-year warranty at no additional cost. The preventative maintenance performed as a part of these warranties is difficult to get approved through county funding, but they are critical to instrument operations. The County budget challenges do not allow for the purchase of these items until after an issue arises, if at all. The effects of COVID-19 are still demonstrated in supply-chain demands, so the process of purchasing new instrumentation could extend even more than before. This results in significant down-time, which cannot be afforded with ever-increasing case work demands.
Aa. Description of the Issue – Revised for budget changes
As described in the original project narrative, the toxicology section cannot operate efficiently when instruments go out of service, whether briefly or permanently. For this reason the county was called on to access restricted funds for the purchase of a new instrument while this grant application was being reviewed. One GC/MS instrument went out of service, despite attempts by the vendor/manufacturer to fix it. The case backlog and turnaround time quickly started to increase, and action needed to be taken before grant funds became available. As a result, there is no longer a need for the second GC/MS instrument originally requested, and the approved funds should be repurposed to an area where they will greatly benefit the toxicology section. Such changes include moving money to the supplies category for consumables used in every day extractions of drugs to be analyzed on the LC-MS/MS and GC/MS instruments purchased with this grant. The rest will go to the purchase of a backup generator to be placed on an LC-MS/MS instrument to prevent damage should there be a brief power outage. It has become an unanticipated regular occurrence to lose power in the laboratory, and even a power flicker causes the instruments to shut down. The LC-MS/MS instruments can become damaged when improperly shut down so hooking up a backup generator will prevent the sudden shutdown during a power flicker and also give analysts a chance to properly shut down the instrument should the power outage last longer. This change could prevent additional maintenance costs, loss of sample from losing refrigeration within the instrument autosampler, and prolong the life of the instrument.