Medical director's annual review?

[jlw]

Does anyone have the blood bank supervisor performing the procedure manual annual review or must it be the Director/Technical Supervisor of immunohematology - who must be an MD, DO, or PhD, according to CLIA - performing the annual review. Currently, our MD medical directors designate that task to me - the blood bank supervisor (only an MT(ASCP)SBB). I have been recently informed that CLIA requires the MD/DO/PhD to perform this task annually. (The MD's approve/sign the procedures initially).

If that is true and it can't be designated to an MT, can someone provide the specific reference so I can update my SOP? -Thanks

[Mabel Adams]

CAP says Medical Director or designee (except if you have a new director, they have to review them once) and I believe CAP has deemed status for CLIA.

[Lcsmrz]

The Medical Director can delegate this responsibility to someone qualified -- an SBB sure sounds OK to me! -- but should delegate this responsibility in writing, such as in meeting minutes or Job Description.

I also like to submit a report to him/her, stating it was completed and what exactly was done for the annual review. Gives 'em a chance to ask questions ...

[Ann Viernes]

See Cliff's thread on the same issue. TJC states clearly that the SOP review task cannot be delegated. We will continue to delegate thorough review to sups and senior techs and subsequently have the medical director sign off as well. That reminds me...I need to revise the SOP for SOPs to include that. And have the medical director sign off!

[Liz]

Even if the designee may revise/review, the Director must then review/approve and sign. The director's signatures are looked for at each CAP inspection.

TRM.31150

Procedure Manual Annual Review

Phase II

There is documentation of at least annual review of all policies and procedures by the current laboratory director or designee.

NOTE: The director must ensure that the collection of policies and technical protocols is complete, current, and has been thoroughly reviewed by a knowledgeable person. Technical approaches must be scientifically valid and clinically relevant. To minimize the burden on the laboratory and reviewer(s), it is suggested that a schedule be developed whereby roughly 1/12 of all procedures are reviewed monthly. Paper/electronic signature review must be at the level of each procedure, or as multiple signatures on a listing of named procedures. A single signature on a Title Page or Index of all procedures is not sufficient documentation that each procedure has been carefully reviewed. Signature or initials on each page of a procedure is not required.

[KKidd]

TJC requirs that the medical dorector or "an individual qualified as a technical supervisor in immunohematology" conduct the review. Another designee is not permitted.

:cool::cool::cool::cool::cool:

[Cliff]

TJC requires that the medical director or "an individual qualified as a technical supervisor in immunohematology" conduct the review. Another designee is not permitted.

Have you read the CFR for who qualifies as a technical supervisor? From what I could decipher, it sounds like it needs to be an MD, or DO.

[reidhospbb]

From the CFR

§ 493.1449 Standard; Technical supervisor qualifications.

(q) If the requirements of paragraph ( of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must—

(1) (i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or

(2) (i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and

(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology.

At our last Indiana Department of Health (deemed by CLIA) we were told that a future inspection would require the job descriptions of the various technical supervisors would have to be in line with the CLIA regs and referred us to this portion of the statute. Doesn't sound like there is too much wiggle room on this one. We have made some inquiries on this and have heard nothing yet.

Any ideas?

[Mabel Adams]

Does anyone require CFR 21 part 11 compliant "electronic signature" of Medical Director on procedure revisions and annual review if you store them only electronically? (JC stipulates signer must be a Technical Sup under CLIA regs so for BB must be an MD equivalent).

- - - Updated - - -

Does anyone require CFR 21 part 11 compliant "electronic signature" of Medical Director on procedure revisions and annual review if you store them only electronically? (JC stipulates signer must be a Technical Sup under CLIA regs so for BB must be an MD equivalent).

[kirkaw]

I was told by my JCAHO inspector last year that the person who signs as the reviewer has to be the person that is listed on your CLIA certificate.

However, our process mirrors Ann's.

[LCoronado]

We were inspected by CAP last fall, and per our checklist TRM.31150 has been deleted. Instead we were given both a Transfusion Medicine Checklist and an All Common Checklist which contains COM.10100, Procedure Manual Review. This requirement states that "There is documentation of review of all policies and procedures by the current laboratory director or designee at least every two years."

TRM.31150

Procedure Manual Annual Review

Phase II

There is documentation of at least annual review of all policies and procedures by the current laboratory director or designee.

NOTE: The director must ensure that the collection of policies and technical protocols is complete, current, and has been thoroughly reviewed by a knowledgeable person. Technical approaches must be scientifically valid and clinically relevant. To minimize the burden on the laboratory and reviewer(s), it is suggested that a schedule be developed whereby roughly 1/12 of all procedures are reviewed monthly. Paper/electronic signature review must be at the level of each procedure, or as multiple signatures on a listing of named procedures. A single signature on a Title Page or Index of all procedures is not sufficient documentation that each procedure has been carefully reviewed. Signature or initials on each page of a procedure is not required.

[Mabel Adams]

All regulators now say bi-annual review of procedures. Since I am JC inspected it has to be my Medical Director. Is anyone doing it electronically and, if so, is 21 CFR part 11 compliant electronic signature required? Or can we just have them sign off however the software does it and that is okay?

[Cliff]

All regulators now say bi-annual review of procedures. Since I am JC inspected it has to be my Medical Director. Is anyone doing it electronically and, if so, is 21 CFR part 11 compliant electronic signature required? Or can we just have them sign off however the software does it and that is okay?

Hi Mabel,

Are you sure about TJC allowing for bi-annual review? The last time I checked, they still required annual review for blood bank procedures.

There is a small way out on this. The MD on the CLIA certificate needs to approve all new and modified procedures, but another person qualified as a technical supervisor (essentially an MD) can do the annual review. For large organizations, that is a big help. We have 3 full-time MDs and one part time. We divided the review up among the 3 full-time attendings.

Also for the 21 CFR Part 11 compliance, I suppose I need to look into that. I designed a site for our blood bank and just finished with an online SOP system that includes MD annual review. We just went live so I have 1 year to look into it. Thanks for bringing it up, I'll ask TJC.

[KathleenSL]

We use EtQ Reliance softare for our document control process. All policies, procedures, forms and reference documents are reviewed annually by the document owner (department supervisor/manager), laboratory director and quality assurance department.

[Mabel Adams]

New TJC rules go into effect in July for bi-annual review.

[estiner]

I was told by my JCAHO inspector last year that the person who signs as the reviewer has to be the person that is listed on your CLIA certificate.

However, our process mirrors Ann's.

I would like the reference from TJC that states the "designee" for review has to be a Technical Supervisor. Both AABB and CAP state the medical director can assign a designee for the review but all new and revised procedures must be signed by the medical director. There is nothing in either documentation that defines the designee to only be a "Technical Supervisor" which I agree is defined by TJC to be MD with pathology credentials. I have never had an AABB or a CAP inspector question the designee status for reviews. Since they supercede TJC, I am curious where this idea originated.

FYI - the new guidelines now require review every 2 years, not annually - YEAH!!

[Mabel Adams]

In the BB QSA stds TJC states that the person doing bi-annual review has to meet the CLIA definition of Technical Sup. It specifically says it can't be delegated. I think there is a general Lab std that says a designee is permitted so the conflicting info is confusing. Sorry, don't have the references at home.