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.

1. 1. 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.

1. 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).  The temperature-controlled storage units are located on the Lawrenceville and Chamblee Campuses:

Centers for Disease Control and Prevention (CDC) Lawrenceville

602 Webb Gin House Rd.

Lawrenceville, GA 30045

Centers for Disease Control and Prevention (CDC) Chamblee

4770 Buford Hwy NE   

Atlanta, GA 30341

3. Task List

CLIN 0001 Validation will be performed on a total of 60 liquid nitrogen storage units (including temperature adjusted units with set-points at -80°C), mechanical freezers at various set-point temperatures (e.g., -20°C & -80°C), or refrigerators.

1. The contractor shall perform pre and post temperature verification on the certified and calibrated measuring devices used for the validations.
2. The contractor shall generate one protocol, including acceptance criteria needed for temperature controlled unit validation, for each temperature storage unit model. At a minimum the validation protocols must include:
   • Unit identification and verification
   • Utility/Electrical verification including but not limited sub-system/component voltage check, breaker/outlet information and critical component check.
   • Environmental control and conditions inspection (e.g. temperature, humidity etc.)
   • Installation verification including but not limited to inspections of equipment clearance, facility conditions, preventative maintenance schedule, unit settings, and unit/accessory conditions.
   • Operational/Performance qualification including but not limited to:
     • Control panel tests and checks
     • Alarm system tests and checks
     • Temperature recovery assessment for empty or new units
     • Power failure tests and checks for empty or new units.
     • Calibration verifications for each measurement device installed or used to measure the unit temperature or liquid nitrogen level. Calibrations shall be performed in accordance with manufacturer or industry best practices.
     • Thermometer verification and calibration.
     • Temperature mapping which shall include at least 12 sensors throughout the unit and 1 sensor adjacent to the unit monitoring device and measured at a minimum of every 5 minutes over a 24 hour period.
3. The contractor shall perform a validation for each unit, which includes performing calibrations, measuring and verifying the temperature throughout the unit by temperature mapping, verifying the thermometers, as well as performing other system tests and verifications.
4. The contractor shall record and report any discrepancies and provide recommendations to resolve related issues based on industry best practices.
5. The contractor will provide recommendations for the placement location of the devices to be used  by the CDC  SampleGuard  (temperature monitoring system) application. These devices will be placed in addition to the internal or external unit temperature devices 

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