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  1. MQSA Insights

PACS: An Ounce of Prevention...

Lately, when it comes to record retention, we have seen facilities laboring under some false assumptions: My facility's Picture Archiving and Communication System (PACS) will last forever; its hard drives will never fail; my PACS doesn't need to be backed-up and doesn’t need regular maintenance, refreshing, or upgrading. Although none of these statements is true, several recent MQSA compliance cases have shown us that some facilities evidently believe these myths.

Maintaining the availability of current and recent mammograms has a significant impact on clinical care. Therefore, section 900.12(c)(4)(i) of the MQSA Final Regulations, "Medical records and mammography reports—Recordkeeping," tells facilities that they must maintain their mammogram images, and sets the length of time for their retention. If a facility fails to maintain its mammograms for the length of time specified by the regulations (for any reason except natural disasters), the facility technically is in violation of the law. What this means for your facility is that, if your PACS fails and images are lost due to preventable reasons, the FDA may take compliance action against your facility.

But the failure of a PACS, and the loss of mammographic images, isn't simply a legal technicality; the loss of their mammograms, current and prior, can put your patients’ health at risk. We all realize how important prior mammograms can be when screening for or diagnosing breast cancer. In addition, it can cost a facility thousands of dollars to attempt image restoration, and the attempt may not even succeed. Proper investments in your PACS infrastructure can prevent a catastrophic loss of images of the kind recently experienced by several certified facilities. One such facility permanently lost over 20% of its mammograms. Another facility is attempting the expensive retrieval of over 6,000 lost mammograms. Our own information technology experts have the following suggestions when it comes to the maintenance and upkeep of your PACS:

  • Invest in backup storage, whether server-based or cloud-based;
  • Ensure that your staff is properly trained on how and when to perform backups;
  • Apply the manufacturer's software updates to your PACS as soon as they're released;
  • Follow the manufacturer's recommendations on hardware maintenance, upgrades and refresh, especially for the hard drives—based on the median lifespan of enterprise hard drives, six years is a reasonable refresh rate for them.

Investing in your PACS isn't simply investing in technology; it's investing in the health and well-being of the patients who come to you for their mammograms and who depend on you to provide them with the best mammography services possible, and it keeps your facility in compliance with the MQSA regulations.

If your PACS malfunctions or fails, you should report it to the MQSA Facility Hotline at 1-800-838-7715.

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