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Lab Working Group Objectives and Activities
 
Laboratory Coordination Objectives for the Year 2019 are available here.​

 

​Objectives ​Example Activities

The Lab Focus Group (LFG) 

  •  Identify laboratory issues that require input from all the networks, in collaboration with DAIDS Clinical Laboratory Oversight Team (DCLOT), to assure that network labs are implementing quality and efficient lab processes. 
  • Identify where economies of scale can be achieved by sharing resources, shared pricing agreements, technician training opportunities, laboratories, etc. and address these opportunities in existing or new working groups as necessary.
  • Identify and address opportunities to harmonize laboratory processes and procedures to reduce redundancy, increase efficiency and clarify expectations, especially at shared site laboratories.
  • Identify areas in lab operations and processes to incorporate principles of GCLP and ensure that data generated are of the highest quality, including but not limited to timeliness, accuracy, and clinical appropriateness. GCLP guidelines will be reviewed on an annual basis.

 

  • ​Monitor reagents or materials for possible issues that may affect multi-networks
  • Review the Cross-Network Guidelines for Diagnosis of HIV infection in general terms and revise as needed to reflect any changes per network.

The ACTG/IMPAACT Laboratory Technologist Committee (LTC)

  • Promote uniform handling, processing, labeling, storage, and tracking of specimens (according to consensus procedures) across all clinical sites and laboratories; maintaining a regularly updated laboratory manual of consensus procedures readily available for access by all ACTG/IMPAACT laboratories
  • Serve as a resource to the NIAID/Division of AIDS, Statistical and Data Analysis Center, Data Management Center, Operations Center, and Clinical Site Monitoring Group; acting as a liaison between site personnel, laboratories, clinics and the leadership of the ACTG/IMPAACT and its contractors as well as facilitating communication and networking among the laboratories, clinics and Data Management Center
  • Provide information and education for laboratory personnel in the areas of protocol implementation, collection and regular export of quality data, regulatory requirements, new procedures and policies.

 

  • Share technical expertise and resolve laboratory issues including but not limited to assay/processing procedures, LDMS use, and laboratory operations. Topics may also include discussions on protocol complexity as well as upcoming novel/esoteric assays.
  • Reviews and updates harmonized laboratory standard operating procedures (SOP)s posted in the ACTG/IMPAACT Lab Manual.

 

The Virology Quality Assurance Advisory Board (VQAAB)

  • Review and approve proposed scoring from VQA proficiency testing (PT) analyses which include programs for Quantitative HIV-1 RNA testing, Qualitative HIV-1 RNA testing, Qualitative HIV-1 total nucleic acid or HIV-1 DNA testing (whole blood and DBS), and genotypic HIV-1 drug resistance testing for reverse transcriptase (RT), protease (PR) and integrase (INT) gene regions.
  • Establish monitoring standards that differentiate between technical problems and non-technical problems (e.g. late data, query unresponsiveness, or data containing patient identifiable information [PII] or protected health information [PHI]).

 

  • Request, review and approve proposed method evaluation/validation studies.
  • Review and approve proposed changes in policies or procedures to promote quality assurance in virology assay testing.
  • Review and approve proposed implementation of external quality control standards for use in virology assay testing.
  • Review and approve changes in VQAAB approval status for protocol testing laboratories.
  • Review proposals for new proficiency testing programs for other virology assays such as: Quantitative HCV RNA, Quantitative HBV DNA, Qualitative HPV DNA.

The Clinical Pharmacology Quality Assurance (CPQA) :

Ensure standard quality assurance for all the protocol-specified assays conducted in DAIDS-sponsored network clinical trials across networks and other partners through the Total Quality Management (TQM) Program. The TQM Program improves the transparency and responsiveness of decision-making regarding results of proficiency testing at DAIDS- funded site laboratories by improving communication and timely access to relevant information.

  • The CPQA Advisory Board (CPQAAB)
  • The CPQA HIV Monoclonal Antibodies and Small Molecule Tissue Pharmacology Working Group (CPQAmAb)
  • The CPQA Cross-Network Clinical Pharmacology Laboratory Forum (CNCPL Forum)
  • Bioanalytical Revision Assay Group (BRAG)
  • Tenofovir-diphosphate (TFV-DP) Assays Working Group (TAWG)
 
  • Develop, review, and/or modify standard operating procedures for the monitoring of external quality assurance and investigation and reporting of root cause and corrective action.
  • Review and revise program-specific proficiency testing results and other questions that affect external quality assurance.

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