Letter To The Honorable Michael Donnelly, Secretary Of The Air Force

Press Release

Date: Nov. 12, 2009
Issues: Defense

Today, U.S. Senator Charles E. Schumer wrote to the Secretary of the Air Force urging him to expedite security certification for Innovation Industries, a company in Johnson, NY that manufactures PharmASSIST pharmacy automation systems for the retail, institutional and government markets. The PharmASSIST system prevents about a 3% error rate in the prescription filling process, in addition to providing the efficiency needed to process the high volume of prescriptions. The USAF, one of Innovation Industries' largest customers, requires that the company's products obtain USAF security certifications to connect to the Air Force network. Innovation Industries has diligently obtained and maintained their certification on three occasions. Recent changes to the process by which certification is determined has resulted in lengthy delays to the recertification of Innovation Industries. The company's application for recertification has been pending for almost two years without any explanation. Such delay in approving recertification may cost the company money, resources and its competitive edge. If recertification is not completed by November 2009, they risk losing the approval to continue to contract with the Air Force.

In an effort to ensure that certification is complete by November, and ensuring a continuity of a critical business for Innovation Industries, Senator Schumer today wrote to Secretary of the Air Force Michael Donnelly urging him to expedite the certification and give an explanation for the delays.

"Innovation Industries has obtained and maintained their certification multiple times but now they are being penalized simply because of the inability of the government to process a security certification in a timely manner," said Schumer. "The delay certification costs the company money and resources and makes them less competitive in their market. It also poses a direct threat to the quality of medical services to our military services members and their families. It is critical that we expedite this certification to ensure that the company can remain competitive and provide top notch service to their customers."

A full copy of the letter is below

The Honorable Michael Donnelly
Secretary of the Air Force
182 Russell Building
Washington, DC 20510

Dear Secretary Donnelly,

I write regarding a situation that was recently brought to my attention by a company in the Southern Tier of New York, Innovation Industries.

Innovation Industries is a growing, upstate NY company that manufactures PharmASSIST pharmacy automation systems for the retail, institutional and government markets. Innovation Industries' headquarters is in Johnson, NY. One of Innovation Industries' largest customers is the United States Air Force (USAF). Since 2002, Innovation Industries has enjoyed a highly successful partnership with the USAF, providing pharmacy automation (bar-coding safety technology, medication counting technology, and workflow software) that helps pharmacies increase efficiency and eliminates the possibility of dispensing errors.

The USAF requirs that Innovation Industries' products obtain USAF security certifications to connect to your network. Innovation Industries was the first pharmacy system to do so and they have diligently obtained and maintained their certification. Innovation Industries' products have been through a formal evaluation\certification process on three occasions. Unfortunately, the process has now changed and its fourth certification has been pending in the Office of the Surgeon General (OSG) for almost two years (since October 25, 2007). Innovation Industries has not received a clear explanation for the delay, nor is the OSG capable of providing a schedule for completion date of the certification process.

General Senty, in his most recent Interim Authority to operate the PharmASSIST program approval letter, stated that he may withdraw the authority to operate if the certification is not completed by November 2009. This would require the USAF pharmacies to unplug their PharmASSIST equipment which would have a direct effect on the quality of medical services to our military services members and their families. Innovation Industries' analysis demonstrates that the PharmASSIST system prevents about a 3% error rate in the prescription filling process in addition to providing the efficiency needed to process the high volume of prescriptions.

This is not only a patient safety issue. The delay is also causing an unnecessary expenditure of resources. In the past two years, Innovation Industries has made desperately needed upgrades to computer workstation hardware. Due to the lack of the certification, however, it was forbidden from upgrading the associated software. Rather than replacing each military pharmacy's hardware and software in one trip, Innovation Industries is now required to schedule a return trip for software upgrades after certification is completed. This will result in additional cost to the government of about $200,000 for the software upgrades trips, simply because of the inability of the government to process Innovation security certification in a timely manner.

Lastly, this delay also significantly obstructs Innovation Industries' ability to compete with large, multi-national automation companies that are also interested in the government's pharmacy automation business. While I completely support the concept of a quality security process for certification of our network, it is not fair that Innovation Industries, which invented the technology and then cooperated and shared intellectual property so that a competitive process could happen, would then be prohibited from even competing in the very process for which their cooperation was required for it even to occur.

Innovation Industries never expected to be showed favoritism in the process, but at the very least they expected a timely security certification process. This is a very reasonable expectation. I am looking for a clear status of the certification, reliable timeline to closure, an explanation for the delays and a more streamline change in the process so I can be assured that this type of delay will not occur again.

Thank you in advance for your immediate consideration of this urgent request. Considering the potential harm of a single medication error and given our great respect for the women and men in uniform, I feel compelled to look for help to resolve this potentially critical situation. I look forward to working together to address this security certification issue. If you have further questions, please do not hesitate to contact Samuel Glover at (202) 224-9261.

Sincerely,
Charles E. Schumer


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