Article from ASSE Plumbing Standards Publication July-Sept. 2012 ASSE/IAPMO/ANSI Series 6000 2012 Revision p. 22-24. Edward Lyczko

The periodic revision of the ASSE/IAPMO/ANSI series 6000 – 2006, professional qualifications standard for medical systems personnel, has been recently completed. The updated standard series is now designated “2012”.

Standard series 6000 parallels the requirements of the current edition of the normally triennially– revised national fire protection Association’s NFPA 99, healthcare facilities code. The reason for the standard series 6000 is that NFPA 99 is it specific requirements (particularly regarding the purview of series 6000, medical gases/vacuum pipe distribution systems) are included in the model plumbing codes.

While NFPA 99 covers the general field of patient medical gas and vacuum pipe distribution systems, it does not specifically address requirements that would allow individuals to become certified to the NFPA 99 requirements of each particular discipline. These separate disciplines are necessary to provide for all aspects involved in the installation, through the maintenance, of pipe medical gas/vacuum distribution systems. The discipline addresses in the series 6000 – 2006 are: Medical Gas System Specialist, Installers, Inspectors, Verifiers, Maintenance Personnel, and Instructors, Bulk Medical Gas Systems Installers and Bulk Medical Gas Systems and Instructors.

The standard series 6000 requirements provide regulatory officials uniform minimum requirements for qualified medical gas systems personnel. In addition the standards present uniform requirements for third-party certifiers to certify individuals to these standards.

The past six standards series 6000 – 2006 paralleled the retirement of the past NFPA 99 – 2005. The newly updated standard series 6000 – 2012 parallels the requirement of the now current NFPA 99 – 2012.

As stated that, NFPA 99 is normally updated triennially. However, because of various reasons, seven years were needed to complete the most recent revision, NFPA 99 – 2012.

To explain some of these reasons, one must remember that NFPA 99 contains requirements not only for medical gas and vacuum systems. NFPA 99 actually encompasses virtually the entire scope of health care facilities constructions and operations regarding patient risks and safety.

The 2012 edition added captures on: fundamentals (building system categories, risk assessments, applications) information technology and communication systems for healthcare facilities, plumbing, HVAC, emergency management, security management and fire protection. Among other NFPA procedures involved in the revision, all of the committees had to complete the procedures of their particular disciplines chapter before the revision of the entire NFPA document could be completed and published as a whole.

Not only were these chapters added but a new requirement dictated that a major transformation of perspective had to be woven throughout the new, and all of the existing chapters. This requirement commands that a new method is to be used in determining the codes effects on health care patients, caregivers and visitors regarding equipment operations.

NFPA 99 has transitioned into determining these effects from “facility based” too” risk-based”. For example in Chapter 5 Medical Gas section, one use of the previous perspectives was in determining medical gas equipment and operations requirements; primary equipment redundancies.

In previous editions of NFPA 99, these equipment requirements were predominantly based on the  classification (title) of facilities that procedures (surgical, electrophysiology, etc.) and other clinical medical gas delivery needs (intensive care and other patient care locations) are administered in. For instance, typical “Hospital” facilities because they provide for “ultimate complexity and risks” of healthcare delivery, were normally automatically rated Level 1. Less than 24 hour patient stay “Ambulatory Surgery Centers” facilities, because they previously, in general, performed “minor” (ear, nose, throat, tonsils, etc.) short-term length surgeries that required only low levels of anesthesia on otherwise healthy patients, were normally automatically rated” level 2”.

Because it must support high levels of patient risk in “Hospitals” (many times life-supporting) Level 1 equipment (Medical Air compressor assemblies, Medical/Surgical Vacuum pump assemblies, etc.) require full redundancy. The full redundancy guarantees 100% reliability regarding the delivery of the life supporting gases/vacuum to potential severely compromised patients.

Because of perceived lower risk Level 2 designate equipment does not require this total redundancy. However, the facility did have to develop an emergency plan that dealt with the loss of each particular gas/vacuum.

For the current 2012 NFPA 99 revision the NFPA 99 Technical Correlating Committee (TCC) acknowledged that continual changes and improvements of our nation’s healthcare industry. For example, regarding medical gas systems, because of the recent exponential improvement of surgical procedures and equipment, “Ambulatory Surgery Centers” facilities have evolved from providing only minor procedures into performing major procedures with the accompanying higher levels of anesthesia that were previously administered only in Level 1 “Hospital” facilities.

Today, the list of procedures performed in “Ambulatory Surgery Centers” is much larger and more complex; Spinal surgery, complex soldier repair and vascular procedures to name a few. Many patients requiring these procedures are also now arriving very sick, having more complicated conditions, including heart disease and diabetes. Also, as previously mentioned, the levels of anesthesia required are much higher- the same as in “Hospitals”.
As a result of this and countless other examples, the NFPA 99 TCC required NFPA 99 – 2012 to be revised to acknowledge this healthcare industry transformation. Therefore, equipment requirement criteria demonstrations are no longer facility based. Equipment requirement criteria demonstrations are now “risk-based” being determined according to” risk” assessments. The previous facilities-based level system of determining equipment operations and redundancies has been replaced by the new “Categories” of risk system.

There are four risk-based “Categories” from Category One “Facility systems in which failure is likely to cause major injury or death of patients or caregivers… systems are expected to work or be able at all times to support patient needs…)” To Category Four, “Failure would have no impact on patient care. See NFPA99 -2012-4.1.
Because there are no medical gas systems that “failure of “would not be detrimental to, or otherwise effect patient care, there are no medical gas systems rated Category Four.

Before the design a medical gas and vacuum systems begins at risk assessments that determine a category of systems equipment and operation needed must be performed by facility manager professionals and others in authority according to NFPA 99 2012 – 4.2 As a result of these new requirements at NFPA 99 – 2012 in these regards, risk assessment of today’s “Ambulatory Surgery Centers” would certainly designate them as being Category One.

Among the many other changes to the 2012 edition, is that NFPA 99 has been elevated from a “Standard” to a “Code”. This basically means that NFPA 99 will now be considered to be on the same level as the other NFPA Codes. It is now intended for incorporation into law intact, as the other NFPA “Codes,” and not simply only by reference.

A major change they’ll influence jurisdictions that have incorporated it into law and instructors who use it to teach with, is the NFPA 99c has been eliminated.
As one can imagine, with the changes of perspectives, the additions of new chapters and the many updates to the continually improving healthcare industry, three years was simply not enough time to properly revise NFPA 99 up to its optimal potential.

Regarding the revision of Standard Series 6000, the only meeting required of the working group was on March 7 /8, 2012. There were 22 members of the working group present, plus myself as Chair and Marianne Waxman, a ASSE Professional Qualifications Coordinator, as Secretary.

Many written proposals were reviewed and voted on. These proposals were meant to bring the standard series up to date with the new NFPA 99 – 2012. Also, any referenced standards and references to the Canadian Standards Association (CSA) medical gas standards were brought up to date. There were a few major changes, not addressing NFPA 99 – 2012, proposed and unanimously approved.

There was much discussion concerning the proposal to add a new standard for bulk system verifiers – 6035. It was presented that there is concern in the industry that a ASSE 6030 verifiers are not well-qualified in the verification of both medical gas supply systems “typically liquid oxygen with the capacity over 20,000 cubic feet), even though presently these bulk systems are within their purview.

It was decided to recommend that the PQ Standards Committee that the systems shall be verified by verifiers certified under a new 6035 standard. This standard has a unique training concept. Certification can be attained by the candidate either by:

1) Successfully completing a minimum 32 hour course to become a verifier of only bulk systems.

2) Obtaining a 6030 verifier certification and then adding the successful completion of an additional 16 hour course regarding only bulk systems.

There was then a concern expressed regarding who is qualified to train 6035 verifiers. It was expressed that 6050 instructors would not be qualified to train 6035 Bulk System Verifiers, even though, presently, 6030 verifiers, who currently verified bulk systems, are in their purview.

It was decided that training of the new 6035 verifier shall be by:

1) A Bulk Medical Gas Instructor certified to ASSE 6055.

2)  An ASSE 6050 Instructor with an ASSE 6035 certification.

3) An ASSE 6050 instructor who successfully completes a 16 hour course regarding only BulK Systems (similar to the additional 16 hours 6035 course).

Any references to Bulk Medical Gas Systems where then removed from the 6030 and 6050 standards.
There was also another major change propose an accepted. It was proposed and unanimously approved that the section in the un-enforceable Annex N(N.1)guidelines for third-party certification agencies would be moved into the enforceable standard 6001-1-1.3.

Also, the 6005 Medical Gas Specialist was renamed Medical Gas Generalist.

With Marianne’s help, the remainder of the process was spent addressing the many comments including a few negative. There were three drafts voted on, with all comments addressed. Marianne and I had our final meeting, addressing the last editorial comments, on June 8, 2012.

The entire working group revision process on this complex multi-discipline and large PQ Standard, with a very sizable and vocal working group was completed in only 12 weeks! The revision has been unanimously approved by a vote of both the Professional Qualification Standards Committee and the Board of Directors.

On August 15, 2012 the ASSE/IAPMO/AN SI series 6000 – 2012 was ANSI approved, designating it again as “An American National Standard.”

The very speedy revision of this standard series was urgently needed by both our nation’s healthcare and medical gas industries. Because of the lengthy period required to revise NFPA 99, the healthcare industry was forced to function without a valuable medical gas code upgraded for seven years. Because Standards Series 6000 parallels the current edition of NFPA 99, the industry was technically in “conflict” until the 6000 was updated to the newest revision of NFPA 99 updates, many which further enhance healthcare patient safety.

As added information, the first draft meeting of the NFPA 99 HEA – PIP Working Group was held August 22/23 in San Diego, California. I anticipate this NFPA 99 revision to require the normal three years.

I am individually thanking our very knowledgeable and dedicated Working Group members for their many contributions. There were numerous proposals with much discussion. The cooperation among everyone was amazing. I am especially showcasing Marianne for her wonderful work as the Standard’s Secretary. Without her excellent skills and complying and printing the drafts and many comments, and helping to address the comments, this speedy revision of this very important ASSE/IAPMO/ANSI PQ Standard would have been impossible!