Electronic DNA Sample Testing Strengthens Documentation of Instrumentation Checks
Written by Matt Murphy & Melissa Seccariccia   

Instruments used for DNA-sample testing in today’s forensic laboratories must be precise in their operation in order to provide accurate and dependable results. To ensure this, there must be timely instrument maintenance and repair. And, most importantly, documentation is necessary to show proper maintenance procedures have been followed.

The Federal Bureau of Investigation has established numerous standards for DNA-testing laboratories to follow: the Quality Assurance Standards for Forensic DNA Testing Laboratories. Among these is Standard 10—Equipment Calibration and Maintenance—that spells out numerous sub-standards regarding frequency of equipment maintenance, evidence of acceptable results, repairs performed, and documentation.
 

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Careful Documentation Mandated
 
Standard 10.2 in particular gets to the core requirement under the equipment calibration and maintenance quality assurance standard. It states: “The laboratory shall have and follow a documented program for conducting performance checks and calibration of instruments and equipment.” Also under Standard 10, all instruments and equipment used in DNA sample testing must have annual performance checks. The laboratory must follow a documented program to ensure that instruments and equipment are properly maintained, and it must retain documentation of maintenance, service, or calibration. Finally, new critical instruments and equipment, or critical instruments and equipment that have undergone repair, service, or calibration, shall undergo a performance check before use in casework analysis.
 
The documentation plays a huge role in the maintenance checks that must be accomplished on instruments, requiring written records or logs for the service performed. To make sure both maintenance and its documentation have been performed, both internal and external audits of a forensic laboratory’s instrumentation maintenance are conducted each year.
 
There are several other reasons why this documentation is important:
 
  • Compared to 10 or 15 years ago, when DNA analysis involved use of more manual procedures, laboratories now use a large number of sophisticated instruments ranging from robotic systems, such as liquid handling workstations and DNA extraction units, to DNA sequence and fragment analyzers.
  • DNA samples can range from minute to large, so careful handling of them is essential to avoid contamination or destruction.
  • Reporting of instrumentation maintenance results can be subpoenaed anytime for use with cases in a courtroom.
 
For decades, forensic laboratories have relied upon manual methods to document maintenance of their instruments. However, using a manual method for this vitally important activity is potentially very risky. The tiniest misstep in the instrumentation maintenance and documentation protocol could drastically change the outcome.
 
Phoenix Lab Opts for Electronic Solution
 
The Phoenix (Ariz.) Police Department Crime Laboratory has for years used manual methods for documenting the maintenance and repairs for instrumentation. This method can quickly become overwhelming, confusing, and prone to error, particularly with instrumentation. According to Janel Smith, DNA technical leader with Phoenix PD Crime Laboratory, “When audited to the Quality Assurance Standards, the majority of the non-conforming maintenance standards seem to be tied to the equipment standard. Sometimes laboratories forget their annual maintenance, or have maintenance done by an outside vendor but don’t do a performance check internally.” Therefore, it’s no wonder that using a manual system to document maintenance protocols can be challenging. “There are so many pieces of equipment that when you handle maintenance with a paper system, things just slip through the cracks,” Smith said.
 
For these reasons, Phoenix PD Crime Laboratory is preparing to use an electronic solution for DNA sample testing. The solution is a DNA sample management software program offered by a Mesa, Ariz.-based company that specializes in offering forensic science case management software tools. Phoenix PD Crime Laboratory has been evaluating the new software for several months, and so far the electronic solution appears to be the right fit for the laboratory’s growing DNA testing needs. Presently, the Forensic Biology Section of the laboratory uses paper logs in some of its sub-laboratories for various equipment. Unfortunately, when a trouble-shooting problem arises with an instrument, laboratory personnel have to locate the logs, examine what has been done, who did it, and then determine the next steps. With the electronic solution, scientists can go in and designate an instrument as being offline so that when someone is preparing a batch, that instrument will not be an option for them to use until it is approved for use. In that way, the software gives an easier way to track what instrumentation is down and what needs to be done to get it back online, compared to the laboratory’s current method of e-mailing everyone in the laboratory’s DNA unit to inform them of what’s occurring and asking if someone can fix it.
 
Software Gives Intervals for When Maintenance is Due
 
“The software will allow us to track who is working on a piece of equipment that is down, what has been done, what still needs to be done, all in one central location,” observed Christie Abbott, forensic scientist at Phoenix PD Crime Laboratory.
 
The software that will be used by Phoenix PD Crime Laboratory provides a log where personnel can set time intervals for needed maintenance. The FBI Quality Assurance Standards mandate that every critical instrument must be checked at least annually for maintenance (such as annual calibrations). The software will list all instrumentation and any upcoming maintenance due dates. If the laboratory takes no action and a due date passes, the software will automatically deactivate the instrument and it will be unavailable for selection when filling out a worksheet. When maintenance is due on a particular instrument, the software will automatically activate the instrument for a maintenance check. This automated action also will occur if the laboratory takes no action itself to indicate whether or not a maintenance check has been done and what results occurred.
 
More Streamlined Audits
 
Once a forensic laboratory has adopted an electronic solution to manage the maintenance and documentation for instruments, this solution will greatly help address another essential, mandatory step: annual audits. Laboratories typically conduct their own internal audits of documentation for instrument maintenance performed. But external audits also are conducted by forensic laboratory scientists from various parts of the country.
 
Smith admits there have been times when crime laboratories she worked at missed required maintenance on some instruments. “If we catch it, we have to make a corrective action,” Smith said. “If the auditor catches it, it’s reported as a finding in violation of federal standards.”
 
The Phoenix Crime Laboratory must have an external audit every other year. External audits must be conducted by DNA analysts who are not from within the Phoenix laboratory. Sometimes, Smith said, the laboratory will contract with the National Forensic Science Technology Center to accomplish audits. The laboratory must have all documentation available for auditors to examine.
 
Electronic “Dashboard” Centralizes Maintenance Status
 
Unlike a manual method of tracking and documenting instrumentation maintenance—where logs are spread out over a massive number of pages in three-ring binders—the DNA sample management program chosen by Phoenix PD Crime Laboratory offers an electronic “dashboard” that keeps protocols and other key reference items centralized. For example, the dashboard displays instruments and reagents requiring attention. Handling these aspects of instrumentation maintenance is essential in the DNA process and for audits. Also, instrumentation is not simply a list of robots, or a genetic analyzer. “It’s everything we do and work with, such as thermal cyclers, balances, robots, centrifuges—every small to large piece of equipment we use in the DNA process,” Smith said. And since the software allows everyone in the laboratory’s DNA section to literally be on the same (digital) page, “You can set up all these intervals since you know maintenance has to be done,” Smith added.
 
Non-compliance Has Serious Consequences
 
Failure to keep up with instrument and equipment maintenance and documentation has serious consequences. If an audit reveals findings of maintenance documentation problems, the laboratory needs to remedy them. “If you get too many findings, then your participation in the national DNA database—CODIS—can be suspended,” Smith said. “More importantly, these documents are public record,” Smith continued. “So, for a court case, your lab’s audit findings can be subpoenaed and you and attorneys can see where your laboratory is not following standards.”
 
Phoenix PD Crime Laboratory’s Abbott offers still another perspective. “It (findings questioned in a courtroom) opens the door for possible question about other protocols and if they were followed. It means that a lab analyst’s personal work can be questioned.”
 
The heavy emphasis on instrumentation maintenance and documentation is part of a DNA laboratory’s main goal: to track and show the natural progression of where DNA evidence samples need to go. In tandem with meeting this goal, an electronic solution for dealing with the entire DNA-sample management process can be most helpful because it enables laboratory personnel to define all of the different instruments that are to be used during each step in their DNA methods. The software tracks which instrument was used for each sample and current status of the instrument pertaining to maintenance and calibration.
 
The DNA process itself—extraction, quantitation, amplification, detection—is always the same, but a DNA laboratory can have different methods for testing. An electronic solution for DNA sample processing should allow the laboratory to configure the kinds of methods it uses in any way desired. Long ago, DNA laboratories did not have the myriad of robots and instruments that are so prevalent today. As laboratories become larger, they must accomplish more work but with fewer resources and staffing. Therefore, by centralizing—in this case—equipment and instrumentation, personnel can be more efficient by having documentation in one central area. This will help facilitate DNA sample processing, and certainly instrument maintenance and documentation, as well as audits of these crucial steps.

About the Authors
 
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it has worked for 15 years as a DNA analyst at state, city, and private forensic laboratories. He is presently Customer Care Manager at JusticeTrax where he also serves as project manager for implementation of the company’s LIMS-plus and LIMS-plus DNA software applications.
 
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it has been a forensic biologist and project coordinator for an accredited government laboratory for five years. Currently, she is Product Manager for JusticeTrax and is responsible for development and planning of all of the company’s forensic laboratory software products. Melissa also is chief designer of the LIMS-plus DNA software product.
 
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