Friday, May 1, 2009

PACS Administrators May Require Certification in Texas

PARCA has offered certification for PACS System Administrators (SAs) since early 2005, resulting in hundreds of professionals being certified under its program. When certification activity began, there was the expectation that at some point in time, formal certification might become a requirement to be a PACS SA. It appears as though Texas may become the first state that will make PACS SA certification a legal requirement. The state senate has a bill pending (SB 1193) requiring certification for anyone who services or supports medical devices. 

PACS is defined by the FDA as a Class II medical device and would therefore be covered by the legislation. This is the intent of the proposed law, as stated in the bill: 

Class II and class III medical devices, such as infusion pumps, replacement heart valves, and implanted cerebella stimulators are used in hospitals and ambulatory surgery centers throughout the state. Currently, there are no certification requirements for individuals who repair and calibrate these devices. Given the critical nature of certain medical devices, patient safety may be compromised when these devices are serviced or repaired by unqualified individuals. While most facilities hire only certified biomedical technicians, there are individuals who represent themselves as capable of servicing these devices who have not received the proper training. C.S.S.B. 1193 amends current law relating to the maintenance and service of certain medical devices in health care facilities and provides a criminal penalty.

As is typical, law makers grasp the impact of hardware failures (infusion pumps, etc.) on patient care, yet do not seem to comprehend the impact of software failures and/or lack of maintenance. Software issues could result in an image to be unavailable for diagnosis, displayed on an un-calibrated monitor, or presented in an improper manner impacting diagnosis; essentially all the issues that a certified PACS SA has been trained to mitigate. However, although not called out specifically in the proposed legislation, the FDA has defined PACS as a medical device and it would be covered as such under the bill. Also of note is that non-compliance with the proposed law, if enacted, would be a criminal act. 

What would be the impact on the PACS SA profession? If you have not looked into certification, this might be the right time to do it, particularly if you live in Texas. If this bill passes, I would not be surprised if other states follow suit. Be aware that it will take time to study and prepare for PACS SA certification: most professionals take about 3-9 months to study for certification. Of course, this timeframe can be compressed by taking some of the classes offered by institutions such as OTech. 

The bill has not yet passed, but seems to have the support of a majority of legislators. If you work in Texas on Class 2 medical devices, now is the time to write or call your state senator to see where they stand on this legislation. 

No comments:

Post a Comment