Annual SOP Review

[Cliff]

Does you transfusion service medical director review each SOP annually?

It sounds like the only person qualified as a Technical Supervisor is a medical director.

Joint Commission Standard QSA.05.01.01 states:

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.

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.

I read the CFR and essentially found this statement with regard to immunohematology:

a) 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.

[tbostock]

No, our Medical Director does not read and sign each SOP. I, as the Technical Supervisor, am his designee for that. He does sign a cover page annually that says that I have reviewed all of the SOPs and that they are up to date. Also, that any changes to SOPs are brought to him throughout the year for review and signature.

But I agree with you Cliff. The JC sure is making things confusing.

[Deny Morlino]

Same process here Terri

[Malcolm Needs ☆]

In the Red Cell Immunohaematology (RCI) Service of the National Health Service Blood and Transplant, we have national documents. These are reviewed annually by Reference Service Managers (RSM's) and Reference Laboratory Managers (RLM's) and others, but at any time a Request for Change (RFC) can be entered into the computer by any staff member of RCI. These RCF's are then discussed by the author, the RSM's, the RLM's, the Head of RCI (who is a Biomedical Scientist) and any other interested parties (such as the individual who made the RFC).

In terms of technical/scientific SOP's (as opposed to Clinical SOP's) the Clinicians are not involved at all, unless by invite, if we feel that there is a need for Clinical input.

With some notable exceptions, most of the Clinicians would not understand the technical/scientific SOP's (and there is no reason why they should). They would, however, be real experts at interpreting the clinical significance of the results obtained from our tests; so they understand the background to the tests, but not necessarily how they are carried out.

With all due respect to the system in the US, I wonder how many of your Clinicians could actually come into the Laboratory and carry out the tests (i.e. actually tell whether the technical/scientific SOP's are correct or incorrect), and, if as I suspect, the number is small, then them reviewing and signing SOP's must be nothing more than a "rubber-stamping" exercise to satisfy the auditors?

:confused::confused:

[Cliff]

Thanks all.

TJC is stating that the annual reviewer must be qualified as a technical supervisor.

Here is a CFR link to those qualifications. http://edocket.access.gpo.gov/cfr_2009/octqtr/42cfr493.1449.htm

Do you have someone who meets these requirements review your SOPs annually?

[Laurie Underwood]

Each section of our lab has a month designated for SOP's to be reviewed. Our manuals are reviewed and signed by our lab director, Medical Director and section supervisor. Each SOP is reviewed and signed by all 3 individuals annually. There is a area at the end of each SOP designated for their signature and date of review. I do know that they look at them, because they have found spelling and grammer mistakes which they have corrected.

[John C. Staley]

Cliff, at my previous place of employment all Transfusion service SOPs were Corporate SOPs. Some facilities did have a few SOPs unique to them but not many and the practice was discouraged. Each quarter a group of SOPs would come due for review. They would be sent out by the corporate Transfusion QA team to all supervisors for review and then at a monthly Supervisors meeting any recommended changes would be discussed and adopted or not. Then that group of SOPs would go to the Corporate Transfusion Medical Director for final review. This would include all SOPs that quarter whether there had been any changes or not. Intitally this was quite a burden but once we became used to it and got the system going it actually worked quite well.

On a side note. Since the last up date all I can do is Quick Replies and I have none of the smilyfaces although they are there when I start a new thread. Am I the only one with this issue? Just curious but I do miss my smilyfaces.

[Malcolm Needs ☆]

No, you are not the only one John (although, if you go to the "More" button at the bottom of the "generic" smily faces, these do tend to work).

:hooray::hooray::hooray:

[velliott]

I got the same deficiency from Joint Commission that there could not be a designee so I changed my process and my medical director does review all SOP's. It's not fair that the other departments can have a designee review their SOP's.

[Ann Viernes]

Cliff

I just read that TJC standard also and reviewed the CFR and came to the same conclusion. A few years ago we delegated sections of our SOPs to supervisors and senior techs to get a thorough review, rather than the medical director signing off every year without being able to read every SOP. Our SOP for SOPs explains the process clearly. If an SOP needs revision, it gets revised, then the medical director reviews it. So he is only reviewing changed SOPs. No inspector has had an issue with this, and they all ask for the SOP on SOPs. We discussed this and decided to continue what we are doing and also have the medical director sign every SOP. Who says you can't have your cake and eat it!

[KKidd]

Thanks all.

TJC is stating that the annual reviewer must be qualified as a technical supervisor.

Here is a CFR link to those qualifications. http://edocket.access.gpo.gov/cfr_2009/octqtr/42cfr493.1449.htm

Do you have someone who meets these requirements review your SOPs annually?

I didn't see immunohematology specifially mentioned. We have never had any problems with the technical supervisor performing the annual review. Our Medical Director reviews and signs every new and updated procedure. The more I read, the more confused I am getting. But this is nothing new!!!!

:confused:

[Cliff]

I agree it can drive you batty trying to decipher this.

At this point I am convinced the SOPs must be signed by a medical director annually.

Here is the CFR. This is at the very end. http://edocket.access.gpo.gov/cfr_2009/octqtr/pdf/42cfr493.1449.pdf

a) 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.

[KKidd]

Thanks Cliff, I hope that his doen't mean that I lose my job as a Technical Supervisor. The cut in pay would hurt! Seriously, I'll pass this on to my manager.

:confuse:

[KKidd]

Another thought( this may be my last one for the day before I blow a gasket) This realates to highly complex testing. Is all of our testing considered highly complex? My brain has stopped working on this one!!!!

:confused::confuse:

[Mary**]

It means that the Pathologist is listed as the technical supervisor. The tech in charge is listed as the "general" supervisor. I believe this is also true for cytology. It is just semantics. Bless our government with...:bonk:

[Liz]

Another thought( this may be my last one for the day before I blow a gasket) This realates to highly complex testing. Is all of our testing considered highly complex? My brain has stopped working on this one!!!!

:confused::confuse:

No, you have to consider what is highly complex to the work team. I have the AbId, adsorption/elution under that category with the apheresis procedures.

[Liz]

Yes, the Clinical Pathologist is listed as the technical supervisor, that is where the s/he signs on the CAP PTs.

[bmarotto]

With all due respect to the system in the US, I wonder how many of your Clinicians could actually come into the Laboratory and carry out the tests (i.e. actually tell whether the technical/scientific SOP's are correct or incorrect), and, if as I suspect, the number is small, then them reviewing and signing SOP's must be nothing more than a "rubber-stamping" exercise to satisfy the auditors?

:confused::confused:

This is exactly how I feel, Malcolm. Our Blood Bank senior technical staff (manager, tech supervisor, senior tech) perform the annual review of SOP's. Our Laboratory policy states the medical directors of the various lab sections may delegate annual review of SOP's and this complies with CAP. The Medical Director reviews and signs all NEW and REVISED SOPs. What we plan to do is create a spreadsheet listing all of all our SOP's (12 volumes) with the effective date of the current version. The medical director will use the spreadsheet to electronically document "annual review" of each SOP. Essentially, the director is just signing off that the current version is still in effect. If there was a revision within the past year, he would have already reviewed and signed off on it. The Blood Bank senior technical staff will continue to document annual review on the procedures themselves. The spreadsheet will only be pulled out if TJC requests to see documentation of annual review by the Medical Director. The Medical Director has more important clinical duties to perform. I see no sense having him spend countless hours reading SOPs that he has already approved.

[L106]

I agree with Malcolm and bmarotto.

[Liz]

On a side note. Since the last up date all I can do is Quick Replies and I have none of the smilyfaces although they are there when I start a new thread. Am I the only one with this issue? Just curious but I do miss my smilyfaces.

Press "go advanced " on the lower right of "quick reply" and you will find what you are looking for.

[Eoin]

Whilst Service Director approves all new and revised SOPs, she has better things to do than read all SOPs annually. That task falls to me as Quality Manager, and I review all anually (using Q-Pulse). I will look at SOPs and what is done in the lab / wards etc, but to be fair staff are good at giving me change control requests if they spot an error or if a procedure is changing. Generally changes, if they are big enough would be project managed by me, so I would know about them anyway. If there are clinical implications, these would be given to the Clinical Director to read and OK (they have probably gone through the Hospital Transfusion Committee at that stage, so again he knows about them). I believe we comply with all requirements and have had no complaints from inspectors (Joint Commission or ISO) yet.

Cheers,

Wayne

[Cliff]

While I agree that is not the best use of a medical directors time, the Joint Commission would disagree with you.

The Standard is pretty clear, and I submitted a clarification to them about this.

The replied saying the medical director must perform the annual review and the review can not be delegated.

[Liz]

The Joint Commission and CAP require that the Medical Director perform the annual review, this must not be delegated. It is clearly written.

[Eoin]

Thanks for that Cliff & Liz,

We do have an annual quality review meeting that looks at all issues in total, and sets quality objectives for the following 12 months.I will talk to the director about the issue.

Cheers

Eoin

[Likewine99]

TJC has gone a little overboard with this reg. I know we have to comply with the standard but in reality, the Med Director really does have better things to do with their time.