Over the last decade the regulatory environment for bulk compressed medical gas (CMG) supply systems at healthcare facilities has evolved, resulting in a demand for more formalised processes to document and certify the training of system technicians.

Many healthcare facility operators, inspectors, and government regulators now require technicians to provide evidence of an applicable third-party certification to perform work on their bulk CMG supply systems. Prior to now, the certification options available to bulk CMG supply system technicians have been limited. However, the Compressed Gas Association (CGA) has launched a certification body to address the growing need for personnel certifications in this area. This article examines this exciting development in our industry and discusses the advantages of technician certifications based on respected industry standards.

Bulk CMG supply systems at healthcare facilities are incredibly complex. A typical healthcare facility bulk CMG supply system has a main cryogenic liquid storage tank with vaporizers and regulators to supply gas for patient care. In order to ensure an uninterrupted gas supply to the facility, the system is also equipped with a back-up supply system, which can be another cryogenic liquid tank or high-pressure cylinders. Alarm contacts are in place to notify the healthcare facility personnel of abnormal conditions, such as main tank low level, reserve tank in use, reserve tank low level, reserve tank failure, or other unusual conditions.

The personnel designing, installing, and maintaining bulk CMG supply systems must be adequately trained and qualified to ensure the reliable operation of such an intricate system.  

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Overview

Three main forces currently drive the regulatory and technician certification processes for bulk CMG supply system technicians. The first of those drivers is National Fire Protection Association’s NFPA 99, Health Care Facilities Code, and NFPA 55, Compressed Gases and Cryogenic Fluids Code. These codes stipulate in considerable technical detail the design, operational, installation, and maintenance requirements for bulk CMG supply systems.

The second is CGA M-1, Standard for Medical Gas Supply Systems at Health Care Facilities. CGA M-1 provides guidance on medical gases industry compliance with NFPA 99 and US Food and Drug Administration (FDA) current good manufacturing practices for prescription pharmaceutical elements.

The third element is ASSE International standard ASSE 6015, Bulk Medical Gas Systems Installers. ASSE 6015 defines training and competency requirements for technicians to be certified for bulk CMG supply system work but does not establish technical requirements for system design or maintenance.

NFPA 55 requires that personnel who install bulk CMG supply systems be qualified to either CGA M-1 or ASSE 6015. ASSE 6015 requires personnel to identify and show knowledge of CGA M-1 in order to be certified for bulk CMG supply system work. 

Introducing the CGA Certification Board

The CGA Certification Board, LLC (CGACB) has been established to provide third-party certification programs based on key CGA standards for personnel in the gases industry.

While the organisation borrows part of its name from CGA, the CGACB is a distinct and totally separate organisation from CGA. As an independent third-party certifier, CGACB will remain impartial and focus on assessing the qualifications and competency of certification candidates. 

CGACB has partnered with B&R Compliance Associates, a leading medical gas industry consultant, to serve as Programme Administrator and provide an impartial assessment of the qualifications and competency of certification candidates. B&R has offered bulk medical gas supply system certification programmes for over 15 years and has trained and/or certified nearly half of the bulk CMG supply system technicians active today. Initially, the CGACB will offer a CGA M-1 Certification for bulk CMG supply system installers. The CGACB will consider developing additional programmes based on the industry’s need for third-party certification on topics covered by CGA’s publication library.

What will CGACB M-1 Certification cover? 

The CGACB M-1 Certification will provide a comprehensive evaluation of a candidate’s knowledge of the process of designing, locating, installing, commissioning, maintaining, testing, removing, and documenting work on a bulk CMG supply system, including:

  • The minimum requirements for the design, installation, maintenance, testing, and removal of all new or upgraded bulk CMG supply systems at healthcare facilities
  • FDA current good manufacturing practice requirements that shall be taken into account to prevent adulteration of the compressed medical gases
  • Requirements from applicable national regulations and model codes.

CGACB M-1 Certification will not address: 

  • Piped distribution systems within the healthcare facility
  • Fabrication of assemblies such as pressure control manifolds that are manufactured in a supplier’s shop and qualified for medical gas service in accordance with the bulk CMG supply system installer’s policies
  • Manufacturing plants or other establishments operated by the supplier or the supplier’s agent for the purpose of storing and refilling portable containers, trailers, mobile supply trucks, or tank cars with medical gases
  • Non-healthcare facilities such as laboratories, pharmaceutical, or biotechnology facilities
  • Medical vacuum systems
  • Supply systems that generate compressed medical gases onsite.

What is the need for a CGACB M-1 Certification?

Bulk CMG supply system installers must be competent in all of the pertinent  standards, codes, and regulations related to the system.

The CGACB M-1 Certification has been developed by subject matter experts with experience in designing, locating, installing, commissioning, maintaining, testing, removing, and documenting work for bulk CMG supply systems and covers real-world skills focused on the specific needs and hazards of the medical gases industry. The CGACB M-1 Certification provides customers, authorities, inspectors, and other stakeholders with a broad understanding of a technician’s competencies. The CGACB M-1 Certification demonstrates that the individual has passed a rigorous qualification process and demonstrated a thorough working knowledge of not only NFPA 99, but also the requirements from applicable FDA regulations, NFPA 55, and CGA M-1.

A CGACB M-1 certification also demonstrates to the same audience those technicians are operating under an appropriate quality management system in compliance with FDA GMP regulations, as each candidate’s company standards operating procedures (SOPs) table of contents contents is reviewed to verify that they meet the requirements of CGA M-1. 

When a healthcare facility operator employs a CGACB M-1 certified technician, they know that their bulk CMG supply system will be installed and maintained by a highly skilled professional and can rest assured that the system will perform at the demanding level of reliability required for their patients. Utilising an M-1 certified technician will also guarantee consistency in the principles of the system design and operation, regardless of what company supplies the gas or equipment for the system.

The CGACB M-1 Certification promises to be a real game-changer for the gas industry. It is also backed by one of our industry’s most respected standards development organisations, with over 100 years of experience of promoting safety in the public interest. The industry-specific basis for this certification, in combination with the broad competencies evaluated, is a significant enhancement over any other bulk CMG supply system certification programmes available today.

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Who should seek certification?

The target audience for the certification is service technicians, managers, and engineers who design, install, and maintain bulk CMG supply systems at healthcare and other healthcare facilities. 

The CGACB M-1 Certification is open to all who have been trained on CGA M-1, understand its requirements, and follow company SOPs that are compliant with CGA M-1. The CGACB certification programme is non-discriminatory in accepting applications and issuing certifications to candidates in regards to membership in any trade, association, or union, and is in compliance with federal and state Americans with Disabilities Act (ADA) regulations.

Steps for obtaining certification

Individuals interested in obtaining the CGACB M-1 Certification can register online at www.CGACB.org or by contacting Bob Sutter at 610-868-7183. Candidates must (1) complete and submit an application, (2) remit their registration fees, (3) provide a copy of the table of contents from their employer’s SOPs, and (4) provide documented proof they have successfully completed training that complies with either CGA M-1 or ASSE-6015.

The certification will be valid for three years or for one year after a significant change to the exam content, whichever comes first.

About the CGA / B&R Compliance

Founded in 1913, the Compressed Gas Association (CGA) is a globally recognised standards development organisation with a library of over 340 standards, guidelines, bulletins, alerts, and position statements on the safe use of industrial gases and equipment. The association manages 27 US and Canadian technical committees responsible for the development and maintenance of publications, presentation of technical seminars and webinars, and preparation of additional educational materials such as eLearning modules and safety posters.

The CGA works with code and regulatory officials to advocate for the advancement of industry safety. The CGA is also very active in the international community, working with ISO, the UN, and other industrial gas associations around the world to develop safety standards that are consistent across country boundaries.

B&R Compliance Associates, LLC was founded in 2002 and operates the industry’s largest suite of training and certification programmes related to medical and food gas compliance. One of the B&R principals, Bob Sutter, sits on the applicable ASSE 6015 and NFPA 99 committees, and is one of the industry experts who helped to develop CGA M-1.