CLIA Medical Director

[spavlis]

The new requirement by CMS, AABB, and CAP requires:

The medical director shall approve all medical and technical policies, processes, and procedures.* The medical director listed on the CLIA license is the individual who reviews and signs all the testing policies and procedures and NOT the transfusion medicine director.

From my understanding this only impacts new or revised testing policies.

Note: I understand from AABB that this includes all major and minor revisions.

How is the Transfusion Community defining "testing" policies?

Are you sticking to true testing like ABO typing or are you including- platelet selection, donor eligibility, irradiating.

Trying to find some clarification on this very difficult requirement.

Thanks

Stephanie

[Mabel Adams]

Fortunately ours are the same person.

[NatishaDixon]

I work at a Blood Bank and our CLIA Medical Director is off-site. We separate SOP updates by department so Collections handles donor eligibility/collection and my Laboratory handles their own updates which includes component manufacturing, center testing, transfusion services, and immunohematology reference testing. Luckily for me, our Corporate Office pre-selects which SOPs involve medical and technical policies, processes, and procedures.

I can try to outline our process in hopes that it can offer some sort of help. Prior to implementation of any new SOP or any update, CO sends it to our document control contacts so we can train staff on the policies and so we can get CLIA Medical Director approval. Typically, we get updates at least two weeks prior to implementation so we aren't frantically running around trying to get approval and staff members trained. Sometimes we aren't that fortunate but oh well . For any new/updated SOP that involves a CLIA regulated task, we print these for our CLIA Medical Director to review; this includes SOPs involving platelet selection, donor eligibility, irradiating, etc. Even if just a typo was corrected, for example changing "is" to "are," we have our CLIA Medical Director approve the SOPs if it involves a CLIA regulated task. At the end of each SOP, we define which alteration was made for each revision of an SOP. This provides a quick guide so a person reading the SOP can know what change to look for. We also have a highlighting for each SOP revision which makes added or changed text more apparent. I find this helpful because searching for the change can be akin to searching for Waldo. This makes it easier for our Medical Director so he's aware if there was a serious change or just a corrected typo. We have a form where we list each SOP that requires approval at that time and our CLIA Medical Director will sign that after he approves the SOPs.

[MAGNUM]

I do have a transfusion services Medical Director, but he also covers other hospitals in the area as their pathologist, so I have always just sent my policies to our laboratory medical director. Ours are done electronically, so it is very easy to do. We use a program called Compliance 360 and in it you can define who reviews what and in what order. All my new procedures are approved by me, then the laboratory director, then the Medical Director who then locks the policy. At 90, 60, 30, and past due I get a message in my email saying that such and such policy is due for review on x day. Then it is only me and the medical director that reviews the policies. Compliance 360 is also a secure program.

[cthherbal]

To streamline our process, I have the Tranfusion Medicine Med Dir review/sign all changes, then it goes to Lab Med Dir (CLIA) for 2nd signature. Seems to be working well.

[DPruden]

We added a second signature line to our SOPs for the CLIA Medical Director, for all the SOPs that he previously had a designee sign off on. It was easier to keep track of this way. We also provide a summary of changes with the SOP.