Question:

In the regs, § 8:43A-9.5 Storage of drugs it says, (d)  All drugs in Schedule II of the Controlled Dangerous Substances Acts and amendments thereto shall be stored in a separate, locked, permanently affixed compartment within the locked medication cabinet, medication room, refrigerator, or mobile medication cart.
Schedule 2 = Fentanyl, Percocet, Dilaudid etc.
What do I do with Schedule 3-5 = Versed, Ativan, Valium, etc.

Answer:

All schedule 2 controlled drugs must be stored in a separate, locked, permanently affixed compartment within the locked med cabinet, med room, refrigerator, or mobile med cart.  In other words, they must be kept separate from Schedule 3-5 controlled drugs.

Question:

If Centers have not received a date for a survey, they should be practicing DOH standards, or are they technically under the BOME?

Answer:

Until a facility is licensed by DOH, it is under the BOME. A facility seeking licensure must be in compliance with the DOH regulations in order to receive an approval for licensing. “Practicing DOH standards does not happen after licensure.”

Question:

Our Center would like to start on site Cadaver Teaching, are there specific guidelines that we need to either apply for or implement? Our Vendor would be onsite and handles all aspects.

Answer:

In 2018, I received the following from CMS:

From a Conditions for Coverage (CfCs) standpoint, there is no issues with doing this as a separate line of business.  If you are doing cadaver labs during ASC hours, that would be a problem based on 416.2. The ASC may not offer services unrelated to the surgeries it performs.  Any mingling of the ASC and separate cadaver lab business would be a violation. 

There are potential infection control issues that the ASC would need to be aware of and mitigate. Is this going to be housed in an area that is carved out from the ASC and not accessible to patients, or are you doing this in the ORs where patients will be seen the next day?   Where are the bodies housed? Who is responsible for cleaning the instruments used during lab? Terminally cleaning the OR rooms, themselves – issues with formaldehydes may exist. Here is the CDC guide for lab procedures, including autopsy: http://www.cdc.gov/mmwr/preview/mmwrhtml/su6101a1.htm

The Cadaver labs is not being offered as a service for ASC patients so if,  set up correctly based on national standards of practice, including OSHA and CDC guidelines, it is not seen as violating the CfCs.  Since this is not an additional service being offered to ASC patients…the CfCs do not apply unless something done in that space were to carry over into the ASC patient world (i.e., infection control, LSC, etc).