A new BAS installed in the facilities of a leading Canadian blood supplier allows the organization to maintain and monitor the precise conditions required in its labs, storage facilities, and donor centers. It also enables Héma-Québec to accurately report on those conditions and document the safety of the blood products in its care.
Blood processing establishments require strict compliance with internationally recognized safety standards pertaining to the collection, screening, preparation, and delivery of blood components. A key element of regulatory compliance is having a quality BAS in place to control and monitor the environment of the facility where the blood is processed and stored.

Héma-Québec, a leading Canadian blood supplier, was created in 1998 as part of the reorganization of Canada's blood management system. The organization, headquartered in Montreal, operates two laboratories and three blood donor centers located in Montreal and Quebec City with a total of more than 250,000 sq ft of space. Last year, Héma-Québec collected more than 256,000 units of blood and provided blood products for more than 80,000 hospital patients.

Complete HVAC Control

Héma-Québec is subject to the regulations governing manufacturing, laboratory, and tissue handling practices established by Health Canada, the country's federally funded health care agency. To meet this challenge, Héma-Québec turned to ACS Montréal Inc. to install a BAS that would provide them with facility-wide accountability and traceability of the environmental conditions in their labs and donor centers.

ACS Montréal installed the Andover Continuum® Facility Management System from Tour Andover Controls. The system provides complete HVAC control of labs, office areas, and 12 cold rooms, including temperature and humidity control, room pressure control, redundant cold room control and monitoring, class 100 cleanroom control, and incubator and agitator monitoring. The BAS also supplies fault alarms for lab equipment and detailed reports of conditions in all the areas it controls, while security guards use a workstation in the command center to monitor equipment alarms and critical temperatures.

In addition, Health Canada required that Héma-Québec's BAS be thoroughly validated before any blood processing operations could begin. ACS Montréal partnered with Héma-Québec for the validation procedure, an extensive commissioning, and qualification process to ensure the regulatory agency that the facility conformed to all design and operating specifications and requirements.

"We were impressed not only by the amount of valuable experience ACS Montréal had in laboratory environmental controls and system validation," said Luc Pelletier, Héma-Québec facility director, "but also that Continuum could provide us with a single integrated system for HVAC control, cold room control and monitoring, and data acquisition. It plays a critical role in ensuring regulatory compliance for our facilities."

Paperless Proof

To facilitate the migration to electronic recordkeeping, ACS Montréal installed Tour Andover Controls' CFR Compliance Pack software on Héma-Québec's workstations. The software provides regulated businesses with the ability to generate paperless proof of regulatory compliance. It includes comprehensive tracking, recordkeeping, archiving, and report generation capabilities to document all system changes and alarms. These features deliver facility-wide accountability and traceability of the environmental conditions at Héma-Québec 24/7/365.

Because proper blood storage temperature is of paramount importance, both Héma-Québec locations have redundant cooling systems, each controlled and monitored by a separate controller. If one system fails, the second is started automatically. In addition, the evaporator defrost cycle is adjustable by the operator to meet each cool room's particular requirements.

"The cooling redundancy looked at first to present a programming challenge," said David Allen, vice president of ACS Montréal Inc. "But we were able to program a custom sequence of operations that enables the cooling systems to switch every 6 to 8 hours (depending on how often the walk-in doors have been opened), with a 10-minute overlap period built into the control sequence."

A programmable operator interface with built-in thermistor is installed in every critical department. The unit features a two-line LCD and a 12-button keypad, which allows lab workers to view the environmental parameters, scroll and view alarm messages, and silence alarms.

Héma-Québec provides a crucial service to Canadians and the BAS plays a comprehensive role in the proper handling of blood at each Héma-Québec location. The BAS allows the organization to maintain and monitor the precise conditions required in its labs, storage facilities, and donor centers and it enables Héma-Québec to accurately report on those conditions and document the safety of the blood products in its care.ES