Peggy Ryan, a Nurse Consultant, would close almost every talk with this important thought, "If it wasn't documented, it wasn't done". No truer words have ever been spoken among healthcare professionals and the subject has been the focus of auditors and surveyors. The reason I bring this up is because departments are getting cited for not following the IFU, not being able to produce documentation of what they did, or how they have trained their staff.
AAMI has a section called Ask George, with George Mills of the Joint Commission, and this topic of documentation came up. Here is his reply:
"Beginning Jan 1, 2017, HTM departments must have documentation on-hand for specific devices at the time of a survey. The current practice allows for follow-up documentation to be provided. So, come January, if we ask for it and you don't have it-you don't have it. I'm going to write you a finding. Meeting Joint Commission standards is not so much about ticking boxes as it is consistently applying critical thinking skills and tools, such as risk assessments, to meet the specific challenges faced within individual healthcare delivery organizations-and keeping detailed records of these processes. Documentation will be required at the time of a survey because if it is not documented, it's not done."
CMS has alerted its team about Endoscopes recently in an update, Audit - Ref:S&C-15-32 Hospitals/CAHs/ASCs, here is a brief quote from that update:
"Surveyors, when surveying hospitals, CAHs or ASCs, must ask during the entrance conference whether duodenoscopes are used. If the answer is yes, then surveyors must request a copy of the manufacturer's instructions for use (IFU) for the duodenoscope(s) as well as any AERs the facility uses in reprocessing duodenoscopes. Further, surveyors must observe endoscopes being reprocessed and should ask the responsible staff to demonstrate and explain how they are adhering to manufacturer's' instructions .... Any identified noncompliance must be cited accordingly, and the increased risk to patient safety resulting from improper reprocessing should be taken into consideration when determining the appropriate level of citation."
A recent study published by Johns Hopkins study suggests medical errors are the third-leading cause of death in the United States. Earlier in the year, ECRI put out their top ten medical error concerns and not following the IFU was number 5 out of 10. This is just part of what they said, "ECRI Institute estimates that approximately 70% of accidents involving a medical device can be attributed to user error or the technique of use. Many of these incidents could have been avoided if users had a better understanding of the instructions for use and device operation.
Facilities should make training a key part of the acquisition process for new OR technologies, as well as an ongoing consideration for existing technologies."
So what does this all mean? If you do not have a good record system, you need to "tighten it up", make some easy checklists for your staff to follow, work on having documentation on your staff training and record your cleaning verification testing. Yes, HMT might have the PMA on your equipment, but you still need to know what is being done and check them from time to time. You are still the person responsible, it is your equipment.
As you all know, Healthmark has been on the forefront of cleaning verification. We learned a long time ago of the importance of sample policies, in-serving staff and checklists. We have created tools to help you and your staff meet these requirements of documentation for many of our products. We are here to help you provide the best patient care you can with our products. Have questions or need help? Contact us. We will do our best to help you in this area.
In short, the manner in which your facility generates and retains information, trains staff, and the speed with which it can organize, review and produce documents in response to an auditor's request, can be a recipe for success or disaster.