Need CFR reference for annual review of procedures by Medical Director/Technical Supervisor

[Mabel Adams]

Search as I might I can't find the CFR requiring that the Blood Bank Medical Director (aka CLIA Technical Supervisor) review all procedures annually although I know this requirement was mentioned in the AABB teleconference on the new AABB standards a few months back. I can find where they have to sign off on new ones and changes and where they are responsible for the technical processes in use, but not anything that specifically states annual review of unchanged documents.

AABB requires annual review but they don't require that it be the medical director.

Unlike other depts under CLIA, Immunohematology Technical Supervisor can't be anyone but a doctor--no listing in the CFR for the masters and bachelors degrees like it says for Chem and Hem etc.

Can anyone point me to the right regulation?

[adgorn]

I posted a number of helpful links for blood bankers on our site at:

http://www.txmedweb.com/resourceLinks.aspx

The intent was to help regarding validation, but perhaps these may help you too.

Alan Gornik

Sr. VP

Transfusion Management Services, Inc.

[clmergen]

The joint commission requires the same thing and they don't cite a reference other than the CLLIA 88 qualifications for a technical supervisor.

[chu082011]

The joint commission requires the same thing and they don't cite a reference other than the CLLIA 88 qualifications for a technical supervisor.

Hi,

Thank very much for your comment. It help me to think about for my ideals.

Tks again and pls keep posting.

[tricore]

This is from CAP 7/11/11. Don't know if will help. Says biannual for review but AABB still annual. See #4

**REVISED** 07/11/2011

GEN.20375 Document Control Phase II

The laboratory has a document control system.

15 of 76

Laboratory General Checklist 07.11.2011

NOTE: Document control requirements apply to all policies, procedures and forms (including quality

management documents) for all processes and activities that are subject to CAP accreditation.The

laboratory must have a document management or control system to assure that: 1, all copies of

policies and procedures are current; 2, personnel have read the policies/procedures relevant to

their job activities; 3, all policies/procedures have been authorized by the laboratory director, before

implementation; 4, policies and procedures are reviewed at least biennially by the laboratory director

or designee; 5, discontinued policies/procedures are quarantined in a separate file for a minimum

of 2 years after the date of discontinuation (5 years for Transfusion Medicine). It is recommended

that the laboratory maintain a control log listing all current policies and procedures and the locations

of copies (including derivative documents such as card files and summary charts). The control log

may contain other information as appropriate, such as dates when policies/procedures were placed

in service, schedule of review, identity of reviewer(s), and dates when policies/procedures were

discontinued/superseded.

Electronic (computerized) manuals are fully acceptable. There is no requirement for paper copies

to be available for the routine operation of the laboratory, so long as the electronic versions are

readily available to all personnel. However, procedures must be available to laboratory personnel

when the electronic versions are inaccessible (e.g. during laboratory information system or network

downtime); thus, the laboratory must maintain either paper copies or electronic copies on CD or

other media that can be accessed via designated computers. All procedures, in either electronic or

paper form, must be readily available for review by the inspector at the time of the CAP inspection.

Electronic versions of procedures must be subjected to proper document control. Documentation

of review of electronic procedures may be accomplished by including statements such as “reviewed

by [name of reviewer] on [date of review]” in the electronic record. Alternatively, paper review sheets

may be used to document review of electronic procedures. Documentation of review by a secure

electronic signature is NOT required.

Additional requirements regarding procedure manuals are found in section-specific checklists, and

in this checklist in the Collection Manual, Computer Services and Safety sections.

REFERENCES

1) Clinical and Laboratory Standards Institute (CLSI). Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition.

CLSI document GP2-A5 (ISBN 1-56238-600-X). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,

Pennsylvania 19087-1898 USA, 2006

2) ISO International Standard 15189: Medical laboratories—Particular requirements for quality and competence. Geneva: International

Organization for Standardization, 2003

[Liz]

Every two years now by the laboratory director or designee as per CAP new regs.

[dmpollock]

I compiled some regulatory references for this not too long ago. See attachments.

[Mabel Adams]

AABB's proposed changes to the next edition of Standards say every 2 years also. They will go into effect in Nov if approved. I finally found that only the Joint Commission requires annual review by the Medical Director. AABB currently requires annual review but can be anyone designated. CLIA requires review by the Med Dir of new ones and changes and assigns ultimate responsibility to the Med Dir (aka Technical Supervisor, which for BB has to be an MD). I hear that TJC plans to change their BB standards to just say we have to comply with AABB stds so maybe then we can take some burden off the Med Director.

[rockrock]

Regarding the Technical Supervisor , which for BB has to be an MD - has anyone read the AABB Accreditation Information Manual - Process for Evaluating Exceptions to IRL Technical Supervisor Qualifications.

Under Background - "AABB IRL Standards require the technical supervisor to be 1) a licensed physician certified in blood banking/transfusion medicine, OR

2) have SBB or equivalent certification OR 3) possess a doctorate degree in an immunohematology field. When these criteria are not met........

So from the above qualifications the Technical Supervisor per AABB standards can be any of the above. So an MT with an SBB or equivalent certification can be a Technical Supervisor in an IRL, correct?

[Mabel Adams]

That sounds right under AABB, but CLIA still requires an MD. Are IRLs under CLIA? You do testing on human specimens so I think you are but you don't ever get paid directly by CMS (Medicare) so there may not be any teeth in the rules for you? Or maybe the difference is in what transfusion medicine is supposed to cover according to CLIA.

[rockrock]

That sounds right under AABB, but CLIA still requires an MD. Are IRLs under CLIA? You do testing on human specimens so I think you are but you don't ever get paid directly by CMS (Medicare) so there may not be any teeth in the rules for you? Or maybe the difference is in what transfusion medicine is supposed to cover according to CLIA.

AABB is our deemed CLIA provider. Yes we do testing on human specimens and for our IRL most of the samples are patient samples. I was hoping other blood centers in this forum who are also AABB accredited can comment on this.

[JFRhamy]

The Joint Commission lab standards state the the director or designee can perform the annual review of procedures (LD.04.05.09, EP 10).

[Mabel Adams]

I am pretty sure The Joint Commission says that a Technical Supervisor must do the annual review. For Blood Bank, but no other dept of the lab, the CFR defines the Technical Supervisor as an MD. I think the JC stds specifically say for BB that we can't use a designee. Sorry, I don't have the actual stds here at home.

[bkelly]

I am pretty sure The Joint Commission says that a Technical Supervisor must do the annual review. For Blood Bank, but no other dept of the lab, the CFR defines the Technical Supervisor as an MD. I think the JC stds specifically say for BB that we can't use a designee. Sorry, I don't have the actual stds here at home.

AABB assessments references 42 CFR 493.1251 Standard: Procedure Manual. 42 CFR 493.1445 Standard: Laboratory Director Responsibility; albeit, FDA doesnt really include timeframes. You will find those within the accreditation requirements such as AABB, TJC, CAP given deemed status.

[Mabel Adams]

QSA.05.01.01 Elements of Performance #4. The blood transfusion service director or an individual qualified as a technical supervisor in immunohematology * conducts an annual review of the policies and procedures of the blood transfusion service. The annual review is documented.

Note: A designee is not permitted to conduct this review. (red emphasis mine)

Footnote *: Qualifications for a technical supervisor in immunohematology are described in the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) under Subpart M: "Personnel for Nonwaived Testing," §493.1351 - §493.1495. A complete description of the requirement is located at http://wwwn.cdc.gov/clia/regs/toc.aspx .

493.1449 Standard; Technical supervisor qualifications section 'q' specifically statesthat for immunohematology the Technical supervisor must be a doctor. This is not required for other areas of the lab, just blood bank.

If you are inspected by someone besides TJC then maybe they won't insist on these criteria, but if the JC inspects then this is their standard at this point. I have heard that JC plans to change to just requiring that we all adhere to AABB stds but I haven't heard a timeline.

Edited February 12, 2012 by Mabel Adams
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[rockrock]

Thank you for all this helpful information.

[mm_ribc]

FDA Guidance for QA in Blood Establishments 11 July, 1995, which includes references for the CFR 200's and 600's, has been very helpful. In the guidance document you will find an annual review reference and a statement about defining the roles for review, approval, etc... Pages 6 and 7. The CFR's aren't as specific as the AABB standards because they also address manufacturing of pharmaceuticals, biologics, etc... Many times the audit is to determine if you are compliant with your own SOP's.

Edited April 11, 2012 by mm_ribc
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[DeeMc]

Mabel,

Have you heard if TJC has aligned their SOP review standard with CAP and AABB requiring review every 2 years instead of annually?

[JFRhamy]

Here is the link to the standards change for The Joint Commsision, effective July 2013:

http://www.jointcommission.org/standards_information/prepublication_standards.aspx

[Mabel Adams]

Yes, as of July, TJC joins the 2 year band-wagon.

[ANORRIS]

Yes, as of July, TJC joins the 2 year band-wagon.

And it also says or "designee", without explaining what credentials must be had.

So I guess the person in charge of BB, whoever that may be, can be the 'designee" ???

[Deb]

I had asked our Consumer Safety Officer at CBER for a reference within the CFR regarding review of policies. Her reply was that the CFR does not specify annual review of policies.

[Mabel Adams]

CFR does not stipulate annual review but JC requires it (now bi-annualyl). In the BB JC standards it says that it has to be done by someone that meets the personnel definitions under CLIA as a Technical Supervisor, which for BB, but not other lab sections, must be an MD or equivalent. I believe there is a statement in the general QSA standards that says "designee". Be sure to read the BB standards before concluding you can use someone besides an MD. I assume they would say that the more restrictive standard applies if there is a contradiction.