Practice Benefits of Medical-grade Refrigeration


Fall 2012 - Vol. 1 No. 2 - Page #12

The process of integrating new refrigeration units into a clinical laboratory setting can take time, as depending on the size of the operation, a facility may have numerous units, and it is rare to swap out old technology all at once. However, advocating for the acquisition of medical-grade refrigeration units that provide robust temperature monitoring capabilities is a long-term goal that most clinical labs should strive for. Given the variety of reagent storage and other quality control requirements, opting for medical-grade refrigerator and freezer units capable of maintaining a wide range of temperatures with stability and consistency far outweighs any savings realized from purchasing lower-cost, yet inferior commercial units. 

Margaret Mary Community Hospital (MMCH) is a critical access hospital located in rural Indiana. The core clinical laboratory at MMCH performs approximately 180,000 tests per year within a progressive lab environment enabled by such automation as automated blood banking and hand-held phlebotomy positive identification devices. To maximize our testing capabilities, our team also includes a courier, which enables us to provide outreach lab services to our surrounding physicians. Currently, we employ 22 FTEs for our two facility-based labs—the main hospital lab and a satellite lab located in our oncology and outpatient clinic. In 2006, MMCH began the long-term project of replacing all refrigeration units with medical-grade equipment by identifying and evaluating the major suppliers in the field and then determining our space and temperature requirements. 



Find the Right Equipment and Standardizing
Over the course of the last six years, MMCH has been steadily adopting the latest medical-grade refrigeration units throughout our lab sites. During our initial research into this project, we determined that compatibility with the products we store, vendor standardization, ease of monitoring and access, and reliability were the key factors in ensuring operational success with temperature sensitive products and materials. We knew the timetable for transition to total use of medical-grade refrigeration devices would take time, so in adopting this technology, we felt it important to acquire similar units from a single vendor to enable lab-wide continuity and consistency in product and supply storage protocols, access, and status monitoring. 

Enabling electronic temperature monitoring was essential in our initial vendor selection. Features such as clear, visual temperature data and audible, transmittable alarms were deemed necessities, as simply being able to note normal (or abnormal) temperature ranges at a glance provided peace of mind that the integrity of our products was being maintained; no longer were we left wondering if any given refrigerator was maintaining proper temperatures. Likewise, if a unit went out of range for any reason—such as a door being left open accidentally—having an electronic alert structure that could send automatic notices to designated staff as well as document such events, including resolution, was a very appealing functionality.

Regulatory Considerations and Workflow
Our labs store specimens, reagents, quality control materials, media, blood products, and collection tubes and media in our refrigerators and freezers. Thus, the number of devices employed and their relative placement are determined by the most efficient means of access for staff and where the contents will be used in the lab, as well as where the greatest volume of supplies is needed. 

Furthermore, maintaining strict temperature ranges is critical to product performance and compliance with accrediting agencies. The lab is under stringent requirements by various regulatory agencies including CAP, TJC, and the various state departments of health for daily monitoring of refrigerators and freezers, and documentation of maintenance and any deviations from proper temperature ranges. Accordingly, we are required to set range limits for certain products and supplies, as well as have a plan in place to address any out-of-range scenarios. 

All lab team members are ultimately responsible for ensuring that lab temperatures are in compliance at all times by acknowledging the visual status of the units and reacting as assigned to audible and transmitted alarms. More specifically, the process for responding to alerts is shift dependent, as during the day shift, the lab monitors only the lab refrigeration, but during the evenings, the lab monitors all refrigeration and freezer equipment throughout our facilities. In our environment, the electronic monitoring system records the temperature in each refrigeration unit every hour and sends out alerts for any out of range units. Alerts are programmed per device or by groups of units, such as dietary units, lab units, or pharmacy units. When the temperature goes out of the pre-determined range, an alert is send to a computer in the appropriate unit for resolution. We also have a designated medical technologist who reviews and manages the policies and processes related to temperature-sensitive storage for our team. As part of this management, we evaluate temperature trending to monitor the performance of the individual units. As older units begin to slowly fail by gradually yet consistently moving out of proper temperature ranges, we then indicate a replacement is needed and transition to a new unit.

Do Not Underestimate Aesthetics and Ergonomics
As we worked through swapping out older refrigerators due for replacement with new units in a newly constructed lab, the aesthetics of the units began to emerge as an important factor, albeit secondary to performance. Beyond this, we wanted to make sure that the ergonomic elements of the devices would aid in bringing efficiency to our fast paced environment and the varying uses we need refrigeration for. Given the range in ages of our lab work force, ergonomics continue to be an important consideration for all automation and technology acquisitions. With our new, glass-door refrigerators, features such as smooth rolling pullout shelves not only provide better ergonomics, they also enable better product visibility, which in turn enables better stock rotation and management. 



Conclusion
Maintaining proper temperatures and enabling robust monitoring through medical-grade refrigeration cannot be understated in the hospital laboratory setting. The contents of these devices are often essential, costly items directly related to providing positive outcomes for our patients. Reagents, quality control materials, specimens, blood products, media, and tubes are only as reliable and stable as their storage conditions. Our high-quality, efficient, and reliable refrigeration and freezer equipment has helped stabilize our inventory and cost containment. By maintaining product quality within regulatory requirements, we are providing a firm foundation for laboratory testing activities.


Annette Gillman, MT(ASCP), is the laboratory manager at Margaret Mary Community Hospital in Batesville, Indiana. She received her bachelor of science degree from Marian University in Indianapolis and is a member of CLMA and AACCC.

 


Special MLM Buyer’s Guide: 
Undercounter and Countertop Refrigerators

REF1 and REF2 medical-grade, forced-air, countertop refrigerators provide rapid temperature pull-down and consistent, stable temperatures for laboratory needs, even in applications with frequent door openings. The space saving, 19 x 20-inch footprint fits easily on countertops. Each model features non-heated, off-cycle automatic defrost, external digital temperature display in user-selectable Fahrenheit or Celsius, and programmable hi/low temperature alarms with dry contacts for remote alarming. The REF1 and REF2 operate quietly for use in noise-sensitive areas, and are made with a durable stainless steel interior and exterior with epoxy-coated adjustable shelves. Doors have heavy-duty hinges, lock, and are field-reversible. 
> From Follett Corporation

VersaFridge undercounter and bench-top refrigerators and freezers for laboratory applications feature a slide-in-slide-out replaceable modular power pack. In the event of a failure, users can simply swap out the module, instead of emptying the entire unit. VersaFridge is energy efficient, features a 5-year warranty on both refrigeration and freezer modules, and a lifetime warranty on the cabinet. Users can mix and match interchangeable 1.5-inch and 4-inch drawer and wire shelves for a custom unit.
> From Veracity Group

i.Series undercounter laboratory refrigerators feature chamber temperature uniformity and quick recovery, bacteria-resistant powder coatings, reduced condensation, and self-closing doors with a magnetic latch. Units can be placed under counters, left freestanding, or be stacked. The field-reversible door, front ventilation, and drop-down access panels all make these units easy to use and maintain. All i.Series models include the i.C³ user interface that includes 24/7 monitoring and control via a 7-inch, full-color touchscreen. They also offer event acknowledgement, multiple information logs, and report downloading. If additional security is required, the i.D integrated electronic access control option offers the ability to limit access and track user entry. Under counter models include two epoxy-coated wire shelves and all i.Series models are suitable for storing blood products, reagents, vaccines, and samples.
> From Helmer

Undercounter refrigerators and freezers help eliminate temperature and space concerns. Available in two heights for standard 36-inch-high and lower 34-inch-high ADA counters, they also are stackable to provide further effective use of limited space. All models include heavy-duty compressors and forced-air cooling for superior temperature pull-down and immediate recovery. An exterior LED screen displays temperatures in user-selectable Fahrenheit or Celsius, and audible and visual high/low alarming in the event of failure. 
> From Follett Corporation
 

 

 

 

 

 

 

 


Full-size Refrigerators

i.Series laboratory refrigerators offer full-size chamber temperature uniformity and quick recovery with a heavy-duty, forced-air refrigeration system. The i.C³ user interface includes 24/7 monitoring and control via a 7-inch full-color touchscreen. It also offers event acknowledgement as well as multiple information and report downloading. High and low temperature alarms—both audible and visual—immediately notify users of out of range conditions. Optional i.D integrated electronic access control offers secure access for any situation where extra security is required. Laboratory refrigerators include bacteria-resistant powder coating, self-closing doors, and epoxy-coated wire shelves. Custom storage options are also available, including roll out baskets, drawers, and multiple shelf sizes. In addition, laboratories benefit from reduced condensation on boxes and other containers. Available in upright single and double door models, the i.Series is suitable for storing blood products, reagents, vaccines, and samples.
> From Helmer

Jewett blood bank refrigerators are designed to meet international standards for blood bank storage. Five capacities ranging from a 4.7 cubic foot undercounter model to a spacious 51 cubic foot model are available. All models feature an inkless, 7-day graphic chart recorder as well as a hospital-grade plug and adjustable stainless steel drawers. Jewett blood bank refrigerators are built with sample protection features not found in domestic units, including microprocessor controls for temperature regulation, directional airflow for temperature uniformity, key-operated alarms, and set point security. 
> From Thermo Scientific

Upright refrigerators are designed with airflow that delivers cold air to all products through back plenums at six levels in the cabinet, ensuring temperature consistency throughout. A powerful top-mounted refrigeration module eliminates the hanging evaporator and fan assembly found in other designs. The 20 and 24 cubic foot, single door pharmacy refrigerators have cabinet-wide cooling, user-programmable monitoring and alarming, and provide energy-savings. A 3-inch LCD screen displays internal temperature, any open alarms, and current status, and provides navigation to all user-selectable features. Audible and visual alarms include high and low temperature, power failure, door ajar, low battery, and probe errors. User selectable features include alarm set points, backup battery status, password protection, calibration, and refrigeration system controls. An RS-485 port can stream alarms, product temperatures, and system performance to a central monitoring system. Models are standard with stainless steel exterior and interior, and are equipped with either four epoxy-coated shelves or six full-extension, epoxy-coated baskets that move easily even when fully loaded.
> From Follett Corporation

Scientific Select +4°C solid and glass door refrigerators, sliding glass door refrigerators, and -25°C freezers are available in configurations of one, two, or three doors. Chamber capacities include internal volumes of 24, 33, 52, and 80 cubic feet. All Select Series models help meet critical storage needs with a digital LCD 4 x 20-character display and a programmable logic control system with keypad. Additional features include multiple product sensors, 2 to 10 volt DC output, password protection, clock, diagnostic monitoring of defrost, and event logging.
> From Nor-Lake Scientific

Revco lab refrigerators and freezers are designed for laboratory’s demanding applications with features not found in domestic units, including microprocessor controls for temperature regulation, directional airflow for temperature uniformity, key-operated alarms, and set point security. Specialty models are available for blood bank, plasma, pharmacy and enzyme storage.
> From Thermo Scientific

Scientific Select pass-through refrigerators include full-size, reach-in +4°C solid and glass door models. Pass-thru models are available in two, four, and six door configurations with solid or glass door combinations. Chamber capacities include internal volumes of 24, 33, 53, and 80 cubic feet. 
> From Nor-Lake Scientific
 

 

 

 

 

 

 

 


Freezers
i.Series laboratory freezers are available in upright and undercounter models and provide secure storage with the new i.C³ user interface that includes 24/7 monitoring and control via a 7-inch full-color touchscreen. It also offers event acknowledgement, multiple information logs, and report downloading. Programmable defrost allow users to schedule up to four daily defrost events during low use periods. If additional security is required, the i.D integrated electronic access control option offers the ability to limit access and track user entry. Laboratory freezers include bacteria-resistant powder coating, self-closing doors with magnetic latches, and epoxy-coated wire shelves. Upright models include four shelves and undercounter models include two shelves.
> From Helmer

Jewett plasma freezers are designed to meet international standards for sensitive plasma freezing. These plasma freezers are available in five capacities and feature an inkless, 7-day graphic chart recorder as well as a hospital-grade plug and adjustable stainless steel drawers. Jewett high-performance plasma freezers feature high-density, CFC-free, blown-in insulation that conforms to the cabinet shape, reducing gaps and increasing temperature uniformity.
> From Thermo Scientific

Scientific Select Series -86°C ultra-low freezers are designed to meet the demands of heavy-duty, long-term cold storage for clinical laboratory applications. Chamber capacities include internal volumes of 19 cubic feet, 23 cubic feet, and 28 cubic feet. All Select Series models help meet critical storage needs with a digital LCD 4 x 20-character display and a programmable logic control system with keypad. Each freezer unit can issue audible and visual alarms to surrounding staff and/or designated alarm contacts for door ajar and sensor failure, in addition to high/low range breaches. Additional features include multiple product sensors, 2 to 10 volt DC output, password protection, clock, diagnostic monitoring of defrost, and event logging. 
> From Nor-Lake Scientific

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