Under the CLIA'88 rule, there is a change in the personnel standards for directors of high complexity laboratories. They must hold a doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS (2). The rule "grandfathers" in current experienced directors without board certification, and those who have served as directors of a laboratory performing high complexity testing prior to February 24, 2003 and have 2 yr of laboratory training and experience directing high complexity testing.
In addition, the American College of Medical Genetics requires the following to be met for laboratory directors (3). They must have a PhD or MD, have at least 2 yr of experience or postdoctoral training in a clinical laboratory subspecialty, as well as being certified by specialty Boards. Board certification by the American Board of Medical Genetics or Canadian College of Medical Geneticists documents that this individual has both training and experience suitable for a director of molecular testing laboratory. The American Board of Pathology (ABP), the American Board of Clinincal Chemistry (ABCC), and the American Board of Bioanalysts (ABB) also provide recognized board certifications in this subspecialty. The laboratory director must be on site regularly or a accessible to the laboratory. He/she must ensure that the laboratory is in compliance with all regulations and maintains an ongoing quality assement program. The director determines the appropriate tests to be performed, the techniques to follow and the equipment and
Indicator: Turn-Around Time
Important aspect of service to be evaluated
Indicators to be monitored
Threshold for evaluation
Turnaround time from specimen receipt to result reporting of B- and T-cell gene rearrangements done by the PCR method
The percentage of specimens for B- and T-cell gene rearrangements that are completed within 7 d of receipt
Less than 90%
Plan to Monitor Turn-Around Time
Indicator to be monitored
Source of collection
Frequency of collection
Frequency of analysis
The percent of specimens for B- and T-cell gene rearrangements done within 7 d of receipt.
From the data entered and stored in the laboratory computer system; the laboratory computer system indicates the date of receipt and the date of report for each patient sample.
The Molecular Statistics Test Log program is accessed from the computer system to provide a list of all accession numbers in which B- and T-cell gene rearrangement studies were resulted; the total number of cases of B-cell gene rearrangement assays and T-cell gene rearrangement assay are obtained.
The Molecular Statistics Log is printed by the Pathologist in Charge of the molecular laboratory (or designee).
On a monthly Statistic analysis basis, the Section Chief of laboratory collects, tabulates, and reviews the data.
is done biannually. (January to June and July to December) by the Section Chief and the Pathologist in Charge of molecular laboratory.
reagents to be used. He/she reviews, interprets, and reports all lab results and assures their accuracy.
ACMG also specifies qualifications for other laboratory personal such as the supervisor. They are to hold a Bachelors degree and have at least 3 years of experience in medical field. It is recommended that they obtain certification from such agencies as the American Society for Clinical Pathology (Molecular Pathology) or the National Credentialing Agency in which they could become Certified Laboratory specialist in Molecular Biology. Laboratory technologist must hold an undergraduate degree in a biological or chemical field or have at least five years of relevant laboratory experience.
The ability for laboratory personnel to troubleshoot assays and handle unexpected laboratory problems involves the continuous update of their knowledge. Continuing education is an important aspect of quality assement and improvement. This can be handled in several ways such as a journal club in which selected articles are discussed, reviewing results and interpretations of difficult and interesting patient reports, attending appropriate seminars and conferences. Such activities are to be documented for each laboratory member.
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