Every institution, service company, manufacturer, accreditation body, physicists and others must meet the goal and have in place a compliance program and compliance officer that knows the regulations, knows where information can be found to aid in decision-making and performs the job of compliance to assure patient safety.

If this community is going to move forward and solve many of the issues and problems that confront all of us on a daily basis, we cannot do that without a program and a goal. Patient safety is the goal and that can only be reached by compliance.

Currently, there are four Accreditation Bodies: the American College of Radiology (ACR), a private nonprofit organization, and the state of Arkansas (SAR), Iowa (SIA), and Texas (STX). FDA renewed its approval of each of these under the MQSA regulations in 2005. The term of approval is for a period of 7 years. Although the expiration for renewal is April 28, 2013, FDA will continue to annually review each AB’s performance to determine its compliance with the MQSA regulations. (From the FDA’s web site)

The four Accreditation Bodies require facilities to meet standards that are substantially the same as established by the FDA. Each Accreditation Body is required to have an accreditation program that meets MQSA standards or is substantially the same as MQSA standards.

Accreditation Organizations may also receive CMS accreditation.

Accreditation by an Accreditation Organization is voluntary and is not required for Medicare certification. In order to receive accreditation from CMS an Accreditation Organization must apply and demonstrate their ability to meet or exceed Medicare conditions.

However, the over ruling principal in Accreditation of a facility is that one Federal Agency cannot overrule another Agencies authority. In this case, we have FDA and CMS using Accreditation bodies and organizations to do essentially the same function.

The FDA would be the over riding agency with authority when it comes to accreditation of medical devices in facilities.

The FDA allows for an Accrediting Body to meet the FDA’s MQSA standards or be equivalent to the FDA standards for MQSA.

In regards to other modalities including imaging equipment not associated with Mammography equipment, the FDA laws and regulations would still apply.

No Accreditation body or organization can supersede FDA laws or regulations. No Accreditation body or organization can establish standards that do not conform to FDA laws and regulations.

FDA laws and regulations are very clear in that manufacturer’s specification must be adhered to when it comes to medical devices. An Accreditation body or organization cannot make up its own standards for equipment, other than mammography under the MQSA standards.

If the devices at any facility meet manufacture’s specification the accreditation body or organization must take that as the device meeting the FDA standards.

It must be noted that insurance companies or their organizations cannot supersede FDA laws and regulations and demand a higher standard than the manufacturer’s standards for any device.

If you are an Assembler, Installer or Servicer you are required to meet FDA laws and regulations and no more than that.

Do you have a compliance officer?

Do you have a compliance program?

Is your hard copy FDA paperwork in order and available?

What do you do if an Inspector is at a customer location?

Can you refuse access to your operations to a FDA inspector?

What does an EIR mean to your company?

What does a 483 report mean to your company?

Are your form 2579 reports completed and accurate?

Do you know your requirements for filing out a form 2579?

Do you have the safety and reporting systems in place?

What do you do if you fail an FDA inspection?

How do you survive an FDA inspection?

These are just some of the questions that any person responsible for a Hospital In House service program, Asset Management, ISO or Broker operations must be prepared to answer if you are going to survive an FDA inspection.

What can the FDA do to your operations?

Fines, injunctions, seizure, repeat inspections and other enforcement acts as the FDA and States deems necessary to protect the public health, safety and welfare.

In today’s world not being prepared or not knowing your responsibility is not an acceptable policy.

For in House operations, know, in writing, that the Manufacturers (OEM’s), Asset Managers, ISO or Brokers you do business with are in compliance with FDA laws.

For OEMs, Asset Managers, ISO’s or Brokers get into compliance and start obeying the laws.

What does your organization do to prepare?