A Blood Bank Rabbit in King Chemistrys Court

[Elizabeth Pailloz]

Blood Banker here asking about some very LAB specific quality issue. Hope you can help! There is a recent push to have all of the Blood Bank SOPs signed by the CLIA stated lab director every two years. Ths is in addition to our SOPs being signed by our own Blood Bank medical director every year. The BB director is NOT on the CLIA cert.

Supposedly this is a CMS/CLIA issue that is filtering down thr AABB/CAP. Has anyone else incorporated the signing of ALL Blood Bank SOPs by the Pathologist stated on CLIA cert?

[Mary**]

What is the meaning of your title (I like it)?

[Elizabeth Pailloz]

Oh I titled it that because I posted it in CHemistry forum where we BBers are " out of step "with the CLIA regs and feel more at home with FDA/AABB. My hope was to discuss this Pathologist signing issue with Chem or Gen lab folks who may already be experienced with this regulation and have already "lived thru" this . Glad you liked my pun..unfortunately no one answered ...

[Bill]

According to the CLIA, CMS, AABB regs, the "Director" signature that they are looking for is the "Director" listed on your CLIA and/or state certificate. One place I worked had that happen several years ago when we had part-time pathologist (lab and blood bank director) and the medical staff appointed a hematologist/oncologist as Blood Bank Medical Director to oversee the clinical aspects of blood bank/transfusion service.

[bhunterlabguy]

This "signing" only applies to patient test procedures, not other policies, procedues or processes, and is currently a hotly debated topic...

[L106]

This "signing" only applies to patient test procedures, not other policies, procedues or processes, and is currently a hotly debated topic...

I don't think this is true. Three items in our recent CAP Accreditation Checklist (dated 6/17/2010) address this topic:

TRM.31150 "There is documentation of at least annual review of all policies and procedures by the current laboratory director or designee."

TRM.31155 "The director (or a designee who meets CAP director qualifications) reviews and approves all new policies and procedures, as well as substantial changes to existing documents before implementation."

(CAP defines the "director" as the individual listed on the facility's CLIA registration.)

Donna

[bhunterlabguy]

I don't think this is true. Three items in our recent CAP Accreditation Checklist (dated 6/17/2010) address this topic:

TRM.31150 "There is documentation of at least annual review of all policies and procedures by the current laboratory director or designee."

TRM.31155 "The director (or a designee who meets CAP director qualifications) reviews and approves all new policies and procedures, as well as substantial changes to existing documents before implementation."

(CAP defines the "director" as the individual listed on the facility's CLIA registration.)

Donna

Problematic - Since the CLIA director responsibilities do not allow this set of duties to be delegated, the CLIA director must be available 24 x 7 x 365. The CLIA prosgram only appllies to patient testing. If CAP requires all polices, etc. to be annually signed by the CLIA director, then it would be an accreditation requirement.

[L106]

I have not had to deal directly with CLIA regulations very much, so I admit that I am not very knowledgable about the specifics of some of the CLIA regulations (such as whether the CLIA director can or cannot delegate any duties to others.) I am much more knowlegable about AABB and CAP requirements and accreditation, and my post was specifically limited to addressing CAP's accreditation requirements.

The original statement and question that Elizabeth posted was: "Supposedly this is a CMS/CLIA issue that is filtering down through AABB/CAP. Has anyone else incorporated the signing of ALL Blood Bank SOPs by the Pathologist stated on CLIA certificate?"

Our laboratory is CAP accredited, and my interpretation and paraphrased response to Elizabeth's question would be: CAP says the director whose name appears on the laboratory's CLIA certificate must review and approve all new policies and procedures (and all revisions of policies and procedures if the revisions involve a substantial change) before they are implemented. Thereafter, the director or someone he designates (such as the pathologist who is in charge of the Transfusion Services department) must review all policies and procedures at least once a year."

Donna

[hmust1]

You may have solved this problem already, but we have the Medical Director sign every policy/procedure when it's created and/or revised. Then we have a Laboratory policy that states who the Director's "designees" are for certain areas, so that others may sign off on the annual reviews. For example, the Blood Bank Supervisor is listed as the Director's Designee for Blood Bank and, therefore, reviews/signs the procedures annually in lieu of the actual Director. Something like this may work for you as well.

[Mabel Adams]

Unless you are accredited by Joint Commission. They specifically state that BB sops must be signed off annually by the BB Medical Director. The rest of the lab can have non-physician designees, but not BB. This is on the first page of the BB standards/EPs. I think it refers back to the CLIA definition of a Technical Supervisor which for BB can be only an MD, not a lab supervisor etc.

[hmust1]

Our hospital is JC accredited, but the Laboratory is also CAP accredited (CAP only, no AABB). Is that why this set up works for us? Or do you think we are missing something by only having the Medical Director sign once with subsequent BBK SPV annual review (per our designee policy)?

[Cliff]

I think it refers back to the CLIA definition of a Technical Supervisor which for BB can be only an MD, not a lab supervisor etc.

For Immunohematology the Technical Supervisor can be an MD, DO or (bizarrely) Podiatrist, plus the required certifications, training experience yada, yada...

[Cliff]

Our hospital is JC accredited, but the Laboratory is also CAP accredited (CAP only, no AABB).

It's not an AABB rule, it's a CMS rule. SO if TJC or AABB is your CLIA inspector, at some point one of them is going to catch you.

I just listened to the TJC Most Challenging Lab Standards 2012 on April 26, 2012 and this was an event they were citing. The person on the CLIA certificate must sign all new / revised SOPs only the annual review can be delegated to a Technical Supervisor and the qualifications for a blood bank TC are pretty tough, a supervisor won't make it.

[hmust1]

I really appreciate all of this new information and discussion! I'm certainly not well-versed in regulatory agencies, but doesn't CAP also have deemed status with JC? In 14 years as a Med Tech, and 5 years as the Blood Bank Supervisor, I've never seen a JC inspector in our Laboratory, let alone the Blood Bank. Technically, we are a small community hospital "Transfusion Service", not a "Blood Bank" (according to FDA criteria). We do not collect donors and the only products we alter are pooled platelets and we thaw/pool cryo. Does that change anything with regard to the CLIA/TJC procedure signing issue?

Our Medical Director does sign all new/revised procedures, but no CAP inspector (nor a CAP checklist, as I'm also doing CAP inspections) has ever even suggested that the MD should be the person signing procedures annually. Perhaps I missing something in the CAP checklist? Or are the organizations just not keeping in line with one another?

[KKidd]

Unless you are accredited by Joint Commission. They specifically state that BB sops must be signed off annually by the BB Medical Director. The rest of the lab can have non-physician designees, but not BB. This is on the first page of the BB standards/EPs. I think it refers back to the CLIA definition of a Technical Supervisor which for BB can be only an MD, not a lab supervisor etc.

I have been trying to tell my manager that as a lowly transfusion service suprevisor that I can't be the designee. Have you been told this directly by the Joint Commission? My last inspector (July '11) did not say anything.

[hmust1]

I'm totally confused now. Here is a snipet from a 2010 AABB Annual Meeting during an "Ask the FDA and CMS/CLIA" presentation (note the underlined section which seems to indicate that anyone who is designated by a laboratory policy can perform the annual review) The respondant, "Ms. Meyers," is a CMS representative:

Question 6: The medical director of our blood bank is not the laboratory director listed on our CLIA certificate. Will we be compliant with CLIA if the medical director reviews and signs off on the blood bank's SOPs?

MS. MEYERS: No, you will not be compliant. 42 CFR 493.1251(d) states, "Procedures and changes in procedures must be approved, signed and dated by the current laboratory director before use," and that means the laboratory director whose name is on the CLIA certificate. Now thereafter, any other reviews that are required by laboratory SOP, such as in an annual review, may be performed by other individuals according to the laboratory's policy.

Our LAB and BBK Medical Director are one and the same and he is on the CLIA certificate. The Laboratory is CAP accredited. We have a Laboratory policy that states the MD's desigee for annual BBK procedure review is the BBK Supervisor (me), AND the MD signs all new and revised procedures. (CAP's requirement now is actually every two years, not annually, even for Blood Bank...but I was planning to continue the annual review to be safe with all other agencies.) My question is, given all of the above circumstances...are we compliant? And if not, can someone please indicate, specifically, why not?

[Mabel Adams]

Yes, hmust1, I think you are compliant. The places that must do otherwise are those that are inspected under the JC Lab standards (usually not the case if you are a CAP Lab) or those that have a different person on the CLIA certificate than the BB Med Director.

CLIA regs don't address annual review although the procedures are supposed to be up to date and the Med Director is ultimately responsible for that. They require that a "Technical Supervisor" sign off on new and changed procedures and for BB that "technical supervisor" must have a medical degree.

TJC Lab standards (in the BB section only) says that your Medical Director must review procedures annually and that they must meet the qualifications of a technical supervisor as defined in the CLIA regulations.

QSA 05.01.01 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 .

AABB requires annual review (going to 2 yrs I think) but it can be done by a designee.

[Eagle Eye]

42 CFR 493.1251(d) states, "Procedures and changes in procedures must be approved, signed and dated by the current laboratory director before use,"

What if you changed your SOP for clarity which doesn't alter the test procedure or what if you updated your SOP to update your equipment list???

[Malcolm Needs ☆]

I have absolutely no idea how this works in the USA (I'll be honest), but in the NHSBT, if there is no material change to an SOP, but there is, nevertheless, a change, .we do not alter the version from, for example SOP1234 version 1 to SOP 1234 version 2, but simply change from SOP1234 version 1 to SOP1234 version 1.1. In this way, those already trained to SOP 1234 version 1 only have to sign to say that they are aware of the minor change, rather than having to be re-trained to SOP1234 version 1.1. All new staff, on the other hand, have to be fully trained to SOP1234 version 1.1.

All that having been said, though, our SOPs are totally owned by the author, and do not have to be signed off by an MD. This is because it is recognised that, whilst the doctors are the experts in clinical aspects of blood transfusion, we are the experts within the laboratory.