Though every person in the laboratory is responsible for his quality of work, the laboratory director carries the overall responsibility; thus, his experience and academic expertise should supersede that of others. Having a PhD degree in natural science, the director in a certified laboratory should have undergraduate and graduate majors in biology, chemistry, pharmacology or toxicology. In some cases, people may qualify if their academic and expertise are equivalent to PhD level. Conducting daily management of the laboratory, supervising authority over the laboratory personnel, establishing and authenticating the SOP, ensuring a workforce of sufficient trained personnel, comprehending all aspects of the laboratory, understanding the scientific basis of all procedures and demonstrating knowledge of regulatory requirements are amongst the formal duties of a director.
Since laboratories required highly trained personnel to review results before they could be released to the customers, the concept of a certifying scientist developed within the drug-testing programs. The director was responsible for this in clinical laboratories, but urine drug-testing laboratories produced enough results to over-burden the director from reviewing them solely. Ensuring that analysts have reviewed their portion of testing, the certifying scientists then conduct their own review of all analytical and chain-of-custody documentation. This process, called layered review, is checked by multiple people and thus decreases the probability of laboratory errors. Certifying scientists release results and document their approval only after a comprehensive review of the testing process for each specimen. Since they are individuals who have typically worked several years in the laboratory before being promoted to review responsibility, their required academic qualification and experience exceeds those of analysts and they ought to demonstrate knowledge of analytical and chain-of-custody procedures. Like the director, they must excel in understanding the requirements for each section of the laboratory, the scientific theory of procedures and knowing the applicable policies.
Having sufficient academic qualification to comprehend the scientific principles of assays, the analyst must be formally certified to perform them. Correctly conducting assays with QA samples and performing proper chain of custody before testing actual specimens can lead analysts to be certified. Their approved certification and its accomplished date are documented in the personnel records.
Though requirements for accessioning/ processing technicians bear no formal didactic requirements, however they must be certified. Furthermore, they must be capable to demonstrate understanding of processing procedures, laboratory information management system (LIMS) operation, chain of custody and specimen acceptability requirements. For example, processing technicians in urine drug-testing laboratories check arriving specimens amongst a minimum of 6 conditions that prevent testing- fatal flaws. Absence of arrival of specimen with CCF is an obvious example of this flaw. Designed to protect the donor, other flaws are regulatory for example a broken tamper-evident seal on the container. Judgment by technicians is required in many other flaws and making decisions of specimen acceptability must be examined as a part of their certification.
In legal proceedings, laboratories are often asked to submit documents that aid testing results as evidence. Due to the technical nature of the documents, the laboratory is required to provide an expert who can clarify the documents and the scientific basis for the testing results in many cases. Triers-of-fact will initially determine the qualification of experts when they appear to testify. Aiding to explain the scientific evidence is the core requirement to testify as an expert. Though precedent, however the standard for experts has become much privileged; generally their credentials equal that of a director. Their job is to simplify and explain in dilute terminologies the documents, their implications and the reason behind the results; they are also required to defend the laboratory while the opposing attorney is carrying cross-examination. Reviewing court records can help to monitor and improve the quality of experts; however, being a complex process, it needs innovative ideas for monitoring and ensuring expertise competence.
To demonstrate qualification and continuing proficiency, drug-testing laboratories must maintain active personnel records by containing resumes of training and experience, job descriptions, copies of licenses/certificates /diplomas and documentation of checklist and documentation of current academics.