Public Health Laboratory Employee Investigation Questions and Answers

Public Health Laboratory Incident Questions and Answers

What is the impact for public health?

    This situation does not mean a significant, increased public health risk for several reasons including:

    • There are multiple layers of information and safeguards built into decisions about how we identify and address environmental health risks.
    • While the evidence indicates accepted scientific procedures were not followed, in the vast majority of cases this would not significantly change the final results.
    • The concerns involve long-term exposure risks, not immediate risks.
    • The systems in question have known about their contamination issue, it’s just that a portion of the results presented may be off by a small margin.

    There are concerns about the precision and reliability of a small portion of the data used for those decisions. It is possible that some assessments were affected either by slightly underestimating a risk or slightly overestimating a risk.

How did this happen?

    The initial review suggests the employee allegedly failed to follow proper procedures to verify instrument calibration, and sought to avoid certain quality control steps that would have potentially invalidated results or caused them to be less defensible. For example, rather than sharing the results from all testing runs, the employee allegedly withheld failing results that may have weakened confidence in the sample results.

Who is the employee in question?

    The employee was removed from lab duties during our investigation, and at this point in the investigation the employee’s name is not public. We will share more information as it becomes available.

How long has s/he been with MDH?

    The employee has been employed at MDH for more than 10 years.

Why can’t you tell us more about him/her?

    During an active investigation, state law limits to what information can be made public. We don’t want to do anything that would jeopardize the investigation or deprive someone of due process.

What were his/her areas of responsibility?

    The employee worked in the Public Health Laboratory’s Organic Chemistry area. The bulk of the employee’s duties involved laboratory analyses of non-potable (untreated) groundwater and surface water to look for volatile organic compounds, gasoline and diesel products. In some cases, the employee conducted analyses of drinking water samples as a backup to other analysts.

How was the alleged misconduct detected?

    In recent years, MDH has added data reviewers and other QA staff to provide stronger oversight and verification of information generated from the lab analysts.

    In late April 2015, an MDH data reviewer noticed some discrepancies and time gaps that indicated certain information was not being presented for final review.

    At that point, the evidence indicated only a limited problem with a specific point in time. However, QA staff continued to examine the data and quality control procedures and by late August it was apparent there was a larger issue that warranted action.

Why are you settling on two years as the initial period of focus?

The two-year initial focus is a reasonable starting point and allows us to develop a clearer picture of the scope of the problem. From there, we will go where the evidence leads.

What are the quality assurance measures in place at your lab?

    The quality assurance measures in place in the laboratory include:

    • Ongoing assessment of each step of testing processes.
    • Observance of standard operating procedures (SOPs) for all aspects of testing.
    • Following testing, a data reviewer examines all data and a separate reviewer examines the reports that are to be sent to clients.

    All lab staff are provided with training, including annual ethics training, and are required to participate in proficiency testing to demonstrate analytical competency.

    The laboratory has a dedicated quality assurance (QA) officer who reports to the laboratory director. The QA officer conducts routine audits and meets with management regularly to inform them of any quality issues.

    In 2014, a dedicated data reviewer was hired to enhance our data review process. It was the more robust data review that enabled us to detect the improper work. The data reviewer and quality assurance officer were the ones who found the initial evidence of the alleged misconduct and were instrumental in determining the scope of the behavior.

What actions is MDH taking in response, and when?

    HR INVESTIGATION: MDH Human Resources Staff worked with MMB to secure an independent investigator to evaluate the alleged misconduct and determine what response may be appropriate. That investigation started the week of August 31, 2015 and is expected to conclude by early October.

    DATA REVIEW: MDH Laboratory staff are currently reviewing two years of data processed by the analyst in question. Using a copy of the original raw data, we will generate new amended reports. These new reports will be compared side by side with the reports from the employee in question to look for any discrepancies. In addition, we are contracting with an outside laboratory services provider to review all our reprocessed work.

    SYSTEMS REVIEW: As a part of this investigation, we will be looking for opportunities to improve our own safeguards, procedures and practices to prevent future problems. This will include:

    • Evaluating and enhancing the internal quality control processes that caught these instances of alleged scientific misconduct.
    • Increasing and improving training beyond what is already in place.
    • Stepping up internal audits of data.
    • Adding new external audits of testing processes.
    • Standardizing the use of Laboratory Information Management System (LIMS) technology to quickly detect potential problems through an audit trail that cannot be circumvented.

What makes you think this problem is confined to one person?

    Initial evidence indicates this was the action of one person, but the external investigation will examine that question as well.

What kind of training did this person receive?

    Our lab hires highly qualified scientists with years of training.

    Employees receive training on proper quality control sample documentation and may undergo remedial training if instances of improper work are detected.

    All employees of the lab receive mandatory ethics training.

When will your investigation be complete?

    We anticipate the external HR investigation to take around a month. We anticipate the reevaluation of lab data will take one month for highest priority results, and three months to complete all reviews.

What steps is MDH taking to make sure this doesn’t happen again?

    As a part of this investigation, we will be looking for opportunities to improve our own safeguards, procedures and practices to prevent future problems. This will include:

    • Continuing to build up the internal quality control process that caught these instances of alleged scientific misconduct.
    • Increasing and improving training beyond what is already in place.
    • Increasing transparency and stepping up internal audits of data.
    • Adding new external audits of testing processes.
    • Standardizing the use of Laboratory Information Management System (LIMS) technology to quickly detect potential problems through an audit trail that cannot be circumvented.