Skip to main content

Efficient Laboratory Workflow Management

BayBiotech.NET

In current times demands on laboratory performance are becoming more intensive as the number of new tests and diseases are adding on to our list as well as a greater demand for accuracy in test results is increasing by a much more controlled regulatory environment.
In order to meet these demands, laboratory personnel are working on an ongoing basis to improve efficiency and productivity through better control over the operation and function of all aspects of the testing process by incorporating automation and use of computerized system wherever possible.

Creation of an efficient Workflow
helps make the entire process cost effective and efficient and a framework for creating a workflow may include:
1. Understanding the issues relating to creating a work list
2. Describe ways to minimize laboratory contamination
3. Understand ways to improve labor efficiency
4. Understand key variables that contribute to testing accuracy
 Explain the importance of sensitivity and specificity
 Describe the relationship between prevalence and predictive value

The core of a good laboratory set-up must focus on providing the practitioner with accurate test results that can be achieved by minimizing the cross-contamination and avoiding loss of in-process test samples at different steps of the test performed.

Two main types of cross-contamination that can occur in a laboratory set-up are:

 Organism contamination from the original sample
 Amplicon contamination, which can occur when aerosols from the amplified product enter the air and ultimately transfer to other sample tubes. Trace amounts of amplicon can initiate additional amplification reactions, potentially leading to false-positive results

Benefits of Automation:

In order to minimize the errors and maximize the accuracy of a test result organizations are implementing automations and the benefits of it include:
 Efficiency gains
 Improved turnaround time (TAT)
 Reduction in laboratory errors
 Overall improvement in patient care

In order to avoid the cross-contamination, the Laboratory design considerations may include:

1. A secluded area for sample preparation. Identify key variables that affect specimen collection and transport.
2. Describe the steps in a sample collection procedure.
3. Define carry-over contamination and describe methods to prevent its occurrence.
4. Describe methods for minimizing sample inhibition.
5. Identify sample preparation procedures that increase the risk of contamination.

In order to avoid the cross-contamination, the laboratory routine process may include:

 Avoiding moving freshly filled pipettes tips over open tubes.
 Use pipette tips that have aerosol plugs.
 Maintain physical separation between preamplified materials and amplified.
 Incorporate barriers such as oil or covers in the amplification reaction mix.
 Follow manufacturer's procedures for daily cleaning and decontamination.
 Identify sources of physical contamination, such as frequent touch-points on workstations, keyboards, telephones, etc.
 Change gloves frequently.
 Change lab coats frequently or utilize disposable gowns.
 Restrict gowns and equipment to single areas.
 Perform laboratory environmental "swipe" tests routinely to check for contamination.
Implement routine monitoring of technologist procedures to ensure strict compliance. To read more on this visit:

http://www.lab-education.org/review_ed_mod/mod01_slide38.htm

Comments

Popular posts from this blog

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...

510(k) Summary or Statement

BayBiotech.NET A premarket notification from a manufacturer must include either a summary of the 510(k) safety and effectiveness information of the product upon which the substantial-equivalence determination is based or a statement that this information will be made available by the 510(k) applicant to any person within 30 days of a written request. As per FDA definition, these are the definition of Summary and Statements: Summaries are released by FDA regarding a 510(k) clearance when requested under the Freedom of Information (FOI) Act whereas Statements are used to arrange for this FOI request to be fulfilled by the 510(k) applicant. 510(k) Summaries: If a summary is included, it must be submitted with the 510(k) notification as per FDA guidelines. The summary must be complete and correct in order for FDA to complete its review of a 510(k) submission. FDA will accept summaries and amendments until it issues a determination of substantial equivalence. If a summary has be...