You may have noticed some frenetic activity by your lab manager lately. Perhaps he has been bugging everyone to fill out employee expectation reports or job descriptions. He has probably been busy gathering the material safety data sheets (MSDS) into a nice, neat binder. And he has certainly been trying to get everyone to clean up after themselves.
If you are wondering what it is all about, he might be preparing for facility accreditation. In an effort to combat fraud and abuse – something that has been running rampant in certain parts of the medical field – the Centers for Medicare and Medicaid Services (CMS) has decided to implement a policy whereby some Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) companies will have to submit to serveral additional rules and regulations. These rules and regulations can seem silly at times, but they are there for very good reasons.
Safety
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Let’s start with some of the easier and more obvious requirements. Safety is obviously a big deal. The CMS wants to make sure that employees and patients are protected. Things like proper dust collection, eye protection and hearing protection will be paramount under new regulations. Make sure you have plenty of dust masks and safety goggles in areas where sanding and grinding will occur. If you are doing any amount of laminations with toxic resins you will be expected to have a mask more suitable to the task, like the painting respirator type.
First aid kits are an absolute must and they must be well stocked. You do not have to have surgical equipment in them but you will need a minimum of antibiotic cream, gauze, bandage tape and eye wash. Speaking of eye wash, I always recommend having a formal eye wash station as well as several portable and disposable eye wash bottles scattered throughout the lab.
There should also be current fire extinguishers at appropriate locations and well lighted exit signs at all exits. One thing that may not be so obvious is evacuation signs. Sure, you may know how to get out in case of a fire but any visitors you have might not. Have signs posted in places they will do the most good and be sure to include ways to evacuate your patients who may not be able to evacuate themselves.
You should also have your MSDS in order and complete. You might think this will be limited to just the hazardous chemicals you use in manufacturing like acetone, paint thinner and laminating resins but you would be wrong. Be sure to include all of the chemicals found in your lab such as soap, ink toner and even those new energy saving light bulbs, which contain mercury and must be handled and disposed of in accordance with state and federal laws.
Component records
The CMS also wants you to keep accurate records of patients and the components they have received. This will mean keeping track of part numbers, lot numbers and serial numbers for each part used in construction of every appliance manufactured.
You probably already track serial and lot numbers in patient charts but do you keep a separate log of them? A good accreditation inspector will be looking for a log with patient names, component model numbers, dates and serial numbers so that you will not have to look through each patient file when there is a recall. This should be done even if you use a central fabrication company (CFab) for manufacturing. Be sure to have your CFab send you copies of invoices with serial numbers and patient names so you can create and update your own log.
Speaking of CFab, do you have a supplier contract with your CFab company? You will need to have one ready for the inspector, as well as any other supplier with whom you might contract. It is not currently required, but at some point in the future each CFab will also have to become accredited and you will need to have copies of their certificates on file. That will also include copies of the owner’s professional certifications. The CMS wants to make sure that each device manufactured is made by someone who knows, and can prove they know, how to make them. Since there are no current standards in place for the manufacture of O&P devices they will have to settle for certificates. Again, this is not currently mandated but is expected to be at some point in the near future.
Performance management
Another thing that the CMS is keen on is what they call the Performance Management Program. This is, essentially, a program where your facility must accumulate data to be used to enhance and improve the performance of goods and services to beneficiaries of Medicare.
This data can include but is not limited to: patient satisfaction surveys, complaints and the timeliness of responses to them, frequency of billing and coding errors, impact of supplier business practices and the adverse events caused by inadequate items or services. What this means to the technician is that we should be logging in all repairs and how we took care of them.
The thought behind this program is not to see how many times you screw up but to track trends and make improvements. For example, if you notice that there are a lot of returns due to straps breaking you can look at what kind of breakage has occurred (was it Velcro ripping, speedy rivets coming loose, improper placement) and take steps to minimize occurrences in the future. If you have a log of repairs, the cause of the failures and the steps you have taken to make sure it does not happen again you can only make yourselves more valuable and profitable.
Inspector perspective
As an inspector, the two things I see that are commonly absent from many labs is the serial number tracking log and the repair log. Most labs have an MSDS log that is reasonably up-to-date and first aid kits that are adequate. They lack basic things like a decent emergency evacuation plan.
Do not think of these as hoops you have to jump through or as silly regulations but rather as tools you can use to help improve the services you provide to your patients. That will make the whole process easier and much more worthwhile.
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