Strengthening the Application of the DAIDS GCLP Guidelines: The Implementation of an Integrated Laboratory Oversight Framework.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, validity, and safety of the clinical research or trial participants and laboratory staff and ensures adherence to regulatory requirements. Acknowledgment and adoption of the DAIDS GCLP Guidelines are critical in building laboratory capacity and preparedness for conducting clinical trials. In collaboration with DAIDS, laboratory experts support the implementation of the DAIDS Integrated Laboratory Oversight Framework (Framework) activities. This article describes the implementation of the GCLP Guidelines, the Framework activities, and the coordinated efforts to strengthen laboratory performance. The Framework activities include four components: Quality Assurance Oversight, GCLP Audits, GCLP Training, and Laboratory Quality Improvement. Comparison of GCLP Guidelines with other regulations or standards, including U.S. Clinical Laboratory Improvement Amendments regulation 42 CFR 493, College of American Pathologists, World Health Organization GCLP, and International Organization for Standardization, ISO 15189:2012 standards, highlighted the differences and similarities to guide integration and harmonization efforts. Processes related to the Framework activities are outlined in detail, including key data derived from the managed activities of over 175 laboratories worldwide. Via the evolution of the DAIDS GCLP Guidelines and laboratory oversight workflows, the laboratories participating in DAIDS-sponsored clinical research and trials have successfully participated in internal and external regulatory audits. The collaborative and integrated oversight approach promotes knowledge-sharing and accountability to support the implementation of the DAIDS GCLP Guidelines and compliance monitoring. Lessons learned have helped with the implementation of the DAIDS integrated laboratory oversight approach and quality oversight programs at multiple laboratories worldwide.

Iatrogenic spinal cord injury with tetraplegia after an elective non-spine surgery with underlying undiagnosed cervical spondylotic myelopathy: Literature review and case report.

Cervical spondylotic myelopathy (CSM) can predispose to acute spinal cord injury and post-operative quadriparesis during non-spine procedures, although few accounts of this phenomenon exist within the literature. To the best of our knowledge, there are only 18 cases reported in the literature including ours with spinal cord injury following elective non-spine surgery with undiagnosed CSM. Due to multifactorial pathophysiology, the maintenance of cervical cord neutrality is not sufficient to ensure that these patients will not sustain cord injury intraoperatively as this solely addresses the role of static factors. Vigilance to factors affecting cord perfusion and vascular compromise, such as the mean arterial pressure (MAP), is imperative. Additionally, further studies should evaluate the role of positioning in the myelopathic patient and whether the steep Trendelenburg position, commonly used in robotic surgeries, contributes to spinal cord venous congestion and resultant cord ischemia in these patients given their baseline stenotic canal. This review illustrates the importance of having a heightened awareness of this common degenerative condition in our aging patient population, often a forgotten underlying medical comorbidity.