Cold Chain Technology Services LLC (CTS) is a Service Disabled Veteran-Owned Small Business started in 2006 by experts from the U.S. Healthcare system specializing in the supply chain, vaccine integrity, medical materiel security, logistics including global austere locations, and health & medical preparedness and response mission. The CTS team of subject matter experts include project managers experienced in large and small scale medical material management and emergency response asset management. The CTS team has direct experience in emergency response deployment, large scale exercises, and pandemic response support. Four (4) of the CTS directors were leads for the CDC’s Strategic National Stockpile (now DSNS) and experienced with the support required to provide for a properly prepared community. Our client base includes a direct funded major metropolitan project area as well as one of the largest healthcare coalitions in the U.S. with 55+ member hospitals; the Metropolitan Chicago Healthcare Council (MCHC).

CTS works cooperatively with the MCHC and the Chicago Bureau of Public Health Preparedness and Emergency Response, leveraging the capabilities of these public and private parties to enhance surge capacity and broaden the scope and reach of the overall metropolitan area emergency response. By applying common policies, procedures, and technology platforms in combinations with joint exercises to test, train, and expose deficiencies critical to continuous improvement, CTS has demonstrated a core knowledge of scoping and executing effective project management in a formal collaborative setting between the City and its largest healthcare coalition. CTS subject matter experts assist the hospital coalition to address the issue of the strict benchmarks and preparedness planning requirements behind the Assistant Secretary for Preparedness Response Hospital Preparedness Program (ASPR HPP) grant funding. Written plans that notionally meet the emergency preparedness mission and its benchmarks is a first step, while managing the resources available to meet those mission objectives, or funding requirements, is a critical second step. It is our experience that detailed preparedness & response plans combined with a detailed spending plan and access to a strong SME team with the ability to identify and remove both internal and external barriers to accomplishing those plans is the key to meeting and continuously improving the overall readiness posture.

CTS understands that medical and health systems in the United States face the increasing probability of major emergencies or disasters involving human infection and pandemic outbreaks. In the event of a large-scale public health emergency in one or more cities, existing medical capacity could be overwhelmed quickly. Such events will severely challenge the ability of health care systems to adequately care for large numbers of patients (surge capacity) and/or victims with unusual or highly specialized medical needs (surge capability). For health and medical response agencies to perform optimally, extensive logistical support is necessary. A critical component of logistical support involves the proper inventory control of critical lifesaving assets. These assets may be drugs, supplies, or equipment (such as ventilators) as determined by the emergency response and preparedness planners. A continuing posture of readiness involves coordinated efforts at many levels across many organizations. One key to asset visibility by many entities at all levels is an electronic inventory management system (IMS). When deployed effectively via policies and procedures developed by key stakeholders, a robust IMS is able to provide real time data “dashboard” to emergency response leads as well as generate written reports for detailed analysis critical to making accurate assessments. Additionally, onsite inspections to ensure that assets are maintained to the correct compliance standards are a critical element of the functioning Quality Assurance / Quality Control (QA/QC) plan. Verifying the presence or lack of availability for a particular asset is fundamental and the data within any electronic system of record must be verified at least annually via a written plan. The QA/QC plan augments all of the hard work performed by providing a document/record of correct material management and oversight. CTS’s technical approach, capabilities, and expertise are a product of many years of proven project management and execution. Our procedures and practices have been developed to ensure that the job (or deliverable) is completed in a manner that also meets applicable regulatory guidelines while adhering to an accepted framework of procedures so that the scope of work may be systematically expanded to meet program growth or contraction. This approach, although more demanding, is the only method which will mitigate potential negative impacts to the ASPR funded assets which may require quarantine, set aside, or destruction, and maintain them in a manner that meets or exceeds applicable regulatory standards such as those presented by the Joint Commission, current Good Manufacturing Practices, or US Pharmacopeia in a state of ready use.

CTS works with the MCHC hospital healthcare system preparedness coordinators, CHSPR preparedness committees/subcommittees, MCHC staff and the CHPH to ensure that all asset oversight policies and procedures work to maintain those materials in a ready state that meets or exceeds all applicable regulatory compliance standards including The Joint Commission standards and current Good Manufacturing Practices (cGMP) guidelines per the FDA for each type of equipment, material, or supply to ensure that all of the emergency management materials under MCHC and CHSCPR are maintained in a ready state as intended by their respective manufacturers to support event response/deployment driven by the MCHC in coordination with the CDPH and guidance protocols for the direction and distribution of medial assets. Most recently, CTS was contracted by MCHC to help its coalition members to develop and execute a Tier1 Asset Control System for Ebola PPE made available under recent Federal grant programs. This Ebola PPE program established 100% visibility between coalition partners of the Ebola PPE assets within the coalition enabling accurate assessments critical to the decision making of the leads during a PHE event. CTS participates in the scheduled bi-weekly conference calls with MCHC providing project status updates to include; updates on scheduled activities, schedule amendments, issues, and other information driving completion of the contract deliverables while also providing additional support or information as requested.

Our staff is trained and experienced with medical material management in biorepositories maintaining select agents under strict security as well as finished pharmaceutical material management. CTS is licensed as a drug wholesale distributor in 46 states, VAWD Verified-Accredited by the National Association of Boards of Pharmacies, VFC Audited, cGMP compliant, and ISO 17025 (certifications pending). CTS has more than 9 years’ corporate experience and 80+ years individual management experience covering the full spectrum of emergency asset management, grant coordination, data analysis, bio pharm production and controls development/integration and operation. CTS is experienced with developing and maintaining electronic tools such as the IMS on large scale collections of assets and biologicals, integrating this electronic tool with a comprehensive quality assurance program including SOP development, compliance guidance, qualification of systems to FDA compliance requirements, and quality reviews to document correct and appropriate oversight of drugs and critical materials.