Clinical and Translational Research Centers (CTRC)

Supports research visits in dedicated inpatient and outpatient research facilities as well as limited mobile services to conduct research visits within the University of Colorado Hospital.

Facilities and Services

• UCH CTRC Core Lab
• Nutrition Services
• Nursing Services
• Whole room Calorimeter
• Sleep laboratory
• Metabolic and exercise testing facilities including RMR and vO2max
• Exam rooms
• Echocardiogram & Vascular Imaging
• Chemotherapy Infusion Center
• Dual-energy X-Ray Absorptiometry (DXA)

University of Colorado Hospital CTRC Core Lab

Occasionally, the laboratory director will negotiate with the investigator to reduce the number of requests for expensive or time-consuming assays. Assays which are not available in the routine hospital lab or the CTRC Core Laboratory are generally expected to be paid for by the investigator's individual research funds; although the CTRC Core Laboratory can often help with sample processing. Any shipment of specimens to an off-site laboratory is the sole responsibility of the investigator.

Results from routine assays completed in the hospital laboratory are available through Clinical Workstation. Results from assays performed at the CTRC Core Laboratory are available through a server. Tom Yaeger, Director of Research Informatics, will work with the investigator to set up a system that works best for the research project.

Approval of additional assays (and requests for current assays) is based on scientific merit. The investigator must initiate the request to add additional assays by writing a letter to the Laboratory Administrator and Chairman of the Scientific Advisory and Research Committee (SARC). Complex requests may need approval of the full SARC.

Supports research visits in dedicated inpatient and outpatient research facilities as well as limited mobile services to conduct research visits within the Children's Hospital Colorado.

Facilities and Services

• Children’s Hospital Colorado CTRC Core Lab
• Nutrition Services
• Nursing Services
• Infusion Center
• Exam rooms
• Procedure room
• Body composition measurement via DEXA, BOD POD, and PEA POD
• Metabolic and exercise testing including RMR and vO2max
• Bronchoscopy
• Cardiac monitoring equipment
• Echocardiogram & vascular imaging

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. 

The Colorado State University CTRC includes the Proteomics and Metabolomics Core, Pharmacology Core, and expects to have the Natural Animal Models Core operational by fall of 2015. All services are provided as fee-for-service resources.

Proteomics and Metabolomics Core
The mission of the Proteomics and Metabolomics Facility is to serve as an enabling resource for research and development programs at Colorado State University.

Pharmacology Core
The CU Cancer Center Pharmacology Shared Resource (PSR), located at Flint Animal Cancer Center at Colorado State University in Fort Collins, Colorado was established to work with researchers and clinicians in a collaborative manner to design and implement studies to measure xenobiotics (drugs, toxicants, natural products, etc.) in biological systems and matrices.

The National Jewish Health CTRC includes an Outpatient Clinic, expert research Nursing Services and a Core Laboratory offering a menu of specialized assays. In addition, the CTRC provides specialized research services such as regulatory support and ECG testing.

All services are provided as fee-for-service resources.

Facilities & Services

• NJH CTRC Inflammation & Immunology Core Lab
• Nursing Services
• Exam rooms
• Procedure room
• Interview room
• ECG machines
• ​Allergy skin prick testing
• Skin biopsies
• Physical exams
• Spirometry
• Phlebotomy
• Skin epithelial barrier measurements
• Interviews for structured questionnaires
• Skin microbiome collections
• Medication administration (topical, oral, IV)
• Sweat chloride testing

National Jewish Health CTRC Inflammation & Immunology Core Lab

Our focus is specialized immunologic assays relevant to immunity and inflammation and not clinical diagnostic assays. We have access to coordinate with the National Jewish Health clinical immunology labs with in-house pricing, providing investigators access to unique immunology and inflammation assays.

All services are provided as fee-for-service resources.

Procedures

• Immunofluorescent Cell Staining (PBMCs, lymphyocytes, RBCs, BAL and induced sputum)
• Flow Cytometry Analysis (Cell Quest Pro and Flowjo)
• Lymphocyte Proliferation Assays (including responses to beryllium and various steroids)
• Proliferation Assays using cancer cell lines to determine the effectiveness of drug therapy
• Cell Culturing +/- various stimulation
• DNA extraction from whole blood and various tissues and skin swabs
• Cell isolations (PBMC, BAL, sputum, CD4+ selection)
• RNA extraction from whole blood and various tissues
• ELISA
• Isolation and storage of serum, plasma, PBMCs, BAL, and sputum; cryopreserve and snap freeze cells; prepare slides and perform differential cell counts; prepare and store urine samples; extract and store/assay supernatants from cell culture; extract buffy coat for storage or DNA extraction; prepare lung biopsies for analysis; prepare lung brushings for analysis; prepare and store whole blood; perform colony forming assays on cell lines; develop new assays as needed.

The University of Colorado Boulder CTRC includes an outpatient clinic located in Wardenburg Health Center, access to expert nursing and nutrition services, and an Integrative Physiology Laboratory.

All services are provided as fee-for-service resources.

Facilities and Services

• Nutrition Services
• Nursing Services
• Exercise physiology testing
• Exam and protocol rooms
• Faraday room
• Metabolic (RMR) carts (PARVO/VMAX)
• Dual Energy X-Ray Absorptiometry (DXA)
• Sleep laboratory
• Cardiac monitoring equipment ECG machines GE Vivid 7 ultrasound machine

University of Colorado Boulder CTRC - Integrative Physiology Lab

Investigation Support Areas

1. Autonomic nervous system/cardiovascular physiology
2. Body composition
3. Exercise testing and intervention
4. Indirect calorimetry

Procedures

• Venous occlusion plethysmography
• Microneurography
• Ultrasound measurements
• Graded exercise testing
• Resting metabolic rate
• Dual energy x-ray absorptiometry

Perinatal Clinical Translational Research Center (CTRC)

The Perinatal CTRC plays a crucial role in successfully carrying out human subject research studies in the fields of Newborn medicine and pregnancy, using subjects in the NICUs, Newborn Nursery, and Labor and Delivery suites on the Anschutz Medical Campus. By facilitating partnerships between our research staff, study investigators, and clinical staff, we are able to create a team effort, which works toward a shared goal of producing optimal research outcomes. The Perinatal CTRC also is committed to providing specialized research-focused nursing care.

Perinatal CTRC nurses come to the patient's bedside, as this is the safest and most ethical manner in which to enroll newborn infants and their pre- or post-partum mothers into research studies. The preterm infants are sometimes tiny, needing complex medical care and unique settings for mothers to deliver their babies. For more information about the following Services and Resources, please contact Lisa Lewis​.

Services and Resources

• Screening and Enrollment
• Informed Consent
• Patient and family education
• Clinical staff education
• Sample collection and processing including:
  
  
  • Blood (maternal or infant)
  • Tracheal aspirates/lavages
  • Cord blood
  • Umbilical Cord/Placenta dissection
    
    
• Anthropometrics and Peapod testing
• Coordination of procedures (echo, ultrasound, x-rays)
• Medication administration
• IV infusions
• Data collection and data entry into electronic databases
• Study Liaison services to assist with:
  
  
  • Research lab collection processes and storage plan
  • Study procedure and guideline creation
  • Study design consultation
    
    
• Cord blood and placental collection and processing