Supports research visits in inpatient and outpatient research facilities within Children's Hospital Colorado.
Facilities and Services
Children's Hospital Colorado CTRC Core Lab
The Children's Hospital Colorado CTRC Core Laboratory services the CU Anschutz Medical Campus, researchers nationally and internationally, as well as industry-supported protocols.
It serves as a reference laboratory for Children’s Hospital Colorado, The Cystic Fibrosis Foundation, and Quest Diagnostics. The Children's Hospital Colorado CTRC Core Laboratory is CAP- and CLIA-accredited and provide trained personnel, reagents,
equipment, and QC capabilities to conduct assays for research studies.
All services are provided as fee-for-service resources.
Assay Information
This laboratory provides comprehensive, highly complex testing services, including: chemistry, special chemistry, pulmonary fluids processing, and cell counts. The Children's Hospital Colorado
CTRC Core Lab is a center of excellence for analysis of Fat Soluble Vitamins, Inflammatory Mediators, etc. Testing methodologies includes: Luminex multiplexed biomarkers (cytokines, chemokines, etc.), UPLC, HPLC, chemilluminescence, ELISA, Nepholometry,
Western Blot, and RIA analysis.
Pulmonary Fluid Processing
The laboratory also performs processing, cell counts, and analysis of sputum, tracheal aspirate, and bronchoalveolar lavage fluid.
Frequently Asked Questions
How is the quality of your measurements evaluated – quality control?
It is the policy of the Children's Hospital Colorado CTRC Core Laboratory to establish and use quality control procedures for all testing
that is done. No patient results are reported if reagents, equipment, methods, or test samples exceed the tolerance limits set for specific control procedures. To the extent appropriate for the matrix of QC specimens tested, the specimens are tested
identically to patient specimens.
The laboratory director and general manager are responsible for developing quality surveillance procedures to detect, reduce and correct deficiencies in the analytical process. QC of reagents and equipment
must include verification of reagents, testing of instrument/equipment functions, and preventive maintenance procedures. Calibration procedures for measuring devices, methods, and equipment are documented. Statistical or other objective QC procedures
are used to validate ongoing performance characteristics of a method in terms of accuracy and precision.
Patient QC includes result review, data verification, and error checking. All manually entered results are verified by a second technologist
and/or a manager of the laboratory.
The general manager and technical manager are responsible for reviewing the QC for each run, and determining if the results can be released. In addition, they will perform periodic review of QC statistics.
It is the responsibility of all technologists/technicians who work in the laboratory to maintain QC records in an organized manner and to complete all record keeping or review that is assigned. All QC checks that are done are documented, and all QC
records are kept a minimum of five years.
What is the turn-around time for the service you provide?
The technical manager schedules the appropriate timing of testing of samples using input from the medical director,
general manager, researchers, and laboratory staff as a function of both testing volume and turn-around time/service requirements from users. The schedule is designed to better utilize resources, maximize quality of care, and minimize delays. The
efficiency of the work flow in the laboratory impacts the quality and efficiency of the testing process. Work flow is evaluated with turnaround time monitors. Specimens for Immunoreactive Trypsinogen (IRT), the nephelometric assays, and vitamin analyses
should have no longer than a 7 day turn-around time. Vitamin D 25OH results are run every Tuesday and Friday.
Who documents the data provided and signs off on the data?
Laboratory reports contain accurate demographic
information, a legible and efficient physical appearance, appropriate comments concerning the specimen, comments about results, reference values, and interpretive information. All clinical testing result reports are generated, either through the Meditech
Laboratory Information System or through a Microsoft Access Program. All requirements as outlined by HIPAA to protect PHI are followed throughout the reporting process.
All laboratory results entered into either the Meditech LIS or through
Access are reviewed by either the General Manager or the Technical Manager before results are released. Additionally, review of the results of all lab tests is performed by a second technologist or Laboratory Manager to verify the accuracy of laboratory
results from worksheet or equipment printouts to the computer systems.
Research results may be reported in an Excel spreadsheet format. Again they must contain accurate sample identification, be of a legible and efficient physical appearance,
contain appropriate comments concerning the specimen and results, units and interpretive information when available. All laboratory results entered into Excel are reviewed by either the General Manager or the Technical Manager before results are released.
Additionally, review of the results of all lab tests is performed by a second technologist or Laboratory Manager to verify the accuracy of laboratory results from worksheet or equipment printouts to the computer systems. Generally, the Excel spreadsheets
are sent in a fashion to preserve any PHI or Research information, such as through password protection, encryption, and the use of private internet drop boxes as appropriate. All Excel spreadsheets are reviewed by either the General Manager or the
Technical Manager before results are released.
Have you had experience providing data for industry?
Our laboratory frequently performs industry studies and provides the data electronically as defined by the individual
company. Usually a Data Transfer Agreement is developed which defines all of the data cells on the spreadsheet, so that data transfer will be compatible with the data management format used by the company. The companies use defined subject for specimen
identifiers to keep the demographics blinded. Once this agreement is developed and signed, a sample data transfer is performed to test that the system works properly. After the spreadsheet is populated with the analytic data for the protocol and clerically
reviewed. The spreadsheet is password protected. Many of our industry clients use secured internet drop-boxes. The laboratory manager is assigned a password for access and the password protected spreadsheet is uploaded to the drop-box for transfer.
Do you have a standard operating procedure?
The NCCLS GP2-A4 fourth edition guidelines are used as a model for documentation of technical procedures in the laboratory. Procedures are created for all tests and for all
significant processes in the laboratory. All procedures are reviewed at least annually. If significant changes are made to a procedure, it is revised and reprinted. A sign-off sheet in the front of the procedure manual(s) provides documentation that
the manual has been read by the technologists/technicians performing the tests included the manual. As procedures are revised, previous editions of the procedure are stored according to the Document Control policy. All procedures are re-reviewed and
re-approved within a reasonable timeframe by the laboratory director or designee when there is a change is directorship.
Provide infrastructure, resources, and dedicated space to conduct clinical research. Available resources include research nursing, nutrition, informatics, statistics, regulatory and compliance support and core laboratory services. Supporting both investigator-initiated
studies including multi-center NIH studies and industry-initiated protocols. All services are provided as fee-for-service resources with federally-funded studies receiving subsidized rates. Only IRB-approved protocols can request CTRC services.