Background and Need –

The Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) currently supports public health programs including biorepository activities. The Informatics and Data Science Branch (IDSB) within the Division of Laboratory Systems (DLS) operates the CDC Biorepository (CBR) located in Lawrenceville, Georgia. CBR’s mission is to preserve CDC’s valuable samples and facilitate CDC program activities that are fundamental to public health surveillance, research, and outbreak response.

There are approximately 6 million biological and environmental samples maintained by the biorepository. Consistent with CBR’s vision to achieve excellence in biorepository science and to align with continual improvement efforts, CBR is implementing a comprehensive Quality Management System (QMS) and need to maintain accreditation by the College of American Pathologists (CAP). CAP accreditation provides CDC programs and stakeholders with confidence in CBR services through an independent assessment of CBR’s commitment to quality, first-class operations, and excellent customer service. In addition, CBR wants assurance that its storage containers are maintaining appropriate temperatures for CDC’s valuable sample collections.

CAP Accreditation requires the following:

• Calibration and calibration verification of storage equipment
• Temperature mapping of temperature-controlled storage units
• Thermometer verification
• Electrical grounding inspection

To meet the CAP and standard QMS requirements, a validation of the temperature-controlled units must be performed. At a minimum, the validation must include system installation verification as well as operation and performance qualifications for in use and new units

Objectives

• To develop procedures for freezer validation that meet or exceed industry standards.
• To validate, in accordance with established procedures, CBR temperature-controlled storage units.
• To prepare successful validation documentation packages to support CBR CAP accreditation

General Scope

Validation of temperature-controlled storage units must be performed by experienced and qualified personnel using certified and calibrated equipment. Site-appropriate procedures and acceptance criteria that meet manufacturer recommendations and industry standards for quality must be developed. Upon approval by CBR staff, the temperature validation plans will be implemented within the agreed upon timeframe. Full documentation of successful validation will be prepared and delivered to CDC.

The validation will be performed on up to 60 liquid nitrogen storage units (including temperature adjusted units with set-points at -80°C) and mechanical freezers at various set-point temperatures (e.g., -20°C & -80°C). 

  Technical Requirements

The contractor must be ISO 17025 accredited

1. Temperature measurement devices must be appropriate for various types of storage units, including refrigerators, liquid nitrogen, and mechanical freezers with multiple set-point temperatures (-20°C & -80°C), must be certified and calibrated to a national or international standard (e.g., NIST), and include a self-contained system for transferring and analyzing the data.
2. The contractor must be experienced performing installation verification, and operational/performance qualifications including but not limited to calibration verification and calibration, temperature mapping, thermometer verification and validation for various types of temperature storage units.
3. The contractor must have experience working in liquid nitrogen environment and be familiar with the associated risks.
4. The contractor must provide documented verification of personnel training and experience for performing the validations.
5. All services provided by the contractor must be completed on-site.
6. The contractor must be ISO 17025 accredited.