First AABB inspection

[aj2018]

I recently took over a small transfusion service.  The department hasnt had a supervisor in over 8 months so the paperwork is piled up, nothing is organized, and not sure if we have some things documented or even tracked. 

 

Its my first time taking over a transfusion service department so its hard to figure out where to start.  We are a small transfusion service, we keep one platelet on hand, we have only about 6 Onegs and the maximum of 20 OPOS units.  We use ProVue, manual gel, and tube and we do limited antibody identification.  As far as equipment we have one blood bank refridgerator for reagents and units, plasma thawer, platelet incubator and a small FFP freezer along with one cell washer and one centrifuge.

I need to get this department in shape...equipment, proficiency testing, testing, temperature documentation, all the reviews that need to be done and what paperwork i need to keep in case the inspectors ask for.

 

We have reports that print daily like patient testing reports that we review.  Do we need to keep those for inspections? 

I understand we have to have forms/tables that outline daily, weekly, monthly, quarterly, annual maintenance on the equipment.  Also, forms that show CAP proficiencies are being done by all techs and are all satisfactory.  Procedures for all the testing need to be reviewed annually. 

 

Im a little bit confused about what I need to have as far as the LIS system as far as checks, documentation..etc.? 

 

Any help regarding AABB/ CAP inspections and regulations, any forms that you can pass on that might help will be greatly appreciated.

 

Thank you

 

[Karrieb61]

Wow, you have your work cut out for you. First of all, with a BB that small, why on earth do you have a ProVue, and manual gel and tubes??? Provues were designed for bigger labs not little ones. Seems like a huge waste of money when you already have manual gel and tubes as a fall-back. Just an opinion

As far as inspections go, dig out the last 2-3 previous CAP and AABB inspection records and see how well the lab did. That will be your first clue as to what they felt were deficiencies that both organizations will look for immediately. Both should send you pre-inspection documents so you will have an idea what they will look at. You should have a  copy of the AABB standards which will be your new bible. You should receive checklists from CAP well in advance to your next inspection which will also tell you what you should have.

The AABB standards will list what records you need to have and how long to keep each kind, usually a maximum of 10 years or forever for problem patients (those with antibodies or other unusual challenges).

Your LIS records should include the validation done on the original systems as well as validation of any significant upgrades. Training records for all your techs should show training completed for LIS use. Others will surely chime in here about this. We are computer free right now so I haven't had to worry about this since I got to my small lab about 8 months ago.

Your proficiencies (I assume you use CAP's PT system?) should be up to date in a binder and show that you do PT on every process. This is one reason why it seems like you have super overkill in your lab in terms of instrumentation. You need to have proficiency on all three methods and twice yearly method comparisons between all three. That's a ton of work!!!

Feel free to send me a private message and I can share more ideas if you like. Gotta head back to the lab now.

[tricore]

If the ProVue was put into service since your last inspections, you will need to have the validation for both the instrument and the LIS if it is interfaced.

"We have reports that print daily like patient testing reports that we review.  Do we need to keep those for inspections? "  We do the patient testing review by printing the report to the computer screen (prints too many pages in our system) we document that it was reviewed.

If the LIS was updated since your last inspection you should have that validation available also.

If your LIS is interfaced with a hospital system you have to have documentation signed by the medical director showing that what is put into the LIS is what displays in the HIS (CAP)

You should have the relevant forms used by the inspectors that you can use to self inspect. You can get the AABB Transufusion assessment documents on line. You have to login as an AABB member (institutional?) to see the forms. The CAP inspection forms are also available on line but your institution should have them or be able to obtain them.

Also, have you reviewed the Quality System for blood bank in place at your institution? That will be looked at by the assessor/inspector. Have any audits been done for blood bank, example: follow unit to the nursing unit, etc, etc.? Does your institution have a transfusion committe or are transfusions coved by another quality committe in the hospital? You will need to show the assessor/inspector those records.

[tricore]

Another thought: what is the temperature range on the refrigerator? Blood storage is 1-6C and reagents are usually 2-8C.

[Dr. Pepper]

"Wow, do you have your work cut out for you." And how. DKarrie's and Tricore's advice is spot-on. If I may add:

 

1. Keep caught up on your paperwork. Get on a daily, weekly, monthly schedule of review as applicable. I'm assuming the last 8 months worth of QC, proficiencies etc. have not been reviewed. Catch up on this as you can. Hopefully evrything that should have been done has been done, just not reviewed. If things have been missed, set up a schedule so that doesn't happen again.

2. Keep all your records organized in readily available files, notebooks etc. Nothing sets a bad tone with an inspector like unorganized or misplaced records.

3. I keep an inspection notebook with things like blood supplier agreement, nursing cont ed documentation, checklist crosswalks ("for standard ... see policy BB-...") and other miscellaneous items you will need at inspection time (and probably not much else!). Inspections are unannounced, so be prepared to be able to pass it even if you're not there.

4. For CAP, don't forget that BB also has to comply with the All Common Checklist as well as the Transfusion Medicine. If you do RPRs or rapid tests in your area you will have to comply with the pertinent areas of the Immunology checklist as well.Your lab might already have adequate lab general policies concerning continuing ed, proficiency testing, quality management etc that you can refer to or keep copies of so you don't have to reinvent the wheel.

You will no doubt get more advice. This site is an invaluable resource, chock-full of smart, experienced, knowledgeable and helpful BBers. Welcome, and good luck.

[Kathy H]

Got money to buy all those fancy analyzers?  I suggest you spend some of that and hire AABB Consulting to come in and help you get your shop in order.  Being an extremely satisfied customer of them myself, I say that their fees are very reasonable and their work product is excellent.  Can't hurt to call them and ask.

[tbostock]

I agree with all suggestions above and have one more:

 

Give yourself a break, and time to figure all of this out.  I've been where you are and it is very stressful.  If an inspector comes soon, be honest with them.  Tell them you just took it over and are working on everything and that you are looking forward to any suggestions he/she will share with you.  Smile and breathe....

[aj2018]

Thanks everyone for the great responses.  Its all been of great help. 

 

I honestly told them that they are spoiled having the ProVue, manual gel and tube with the amount of testing we do.  I think we can be ok if we got rid of the analyzer or the manual gel and just kept two instead of all three.

 

I started getting all the CAP proficiency testing in order for this year and next year.  I also found old CAP surveys that were done in past years and looked up some through CAP online.  Im going to get the checklist for both CAP and AABB and start going through them.  

 

They are def missing documentation for some equipment checks esp the quarterly, and semiannually ones.  I'm gonna make some new tables and forms to keep track of this stuff from now on.  I also started a new form to be used to document observing nurses transfusing units and if they are done correctly.

 

I found the quality plan for the blood bank and the procedure manual.  The last review that was done on the procedures was last year sept 2013.  Does the procedure manual and quality manual need to be reviewed every year? I know the techs have to document reading the procedures every year right? 

[Auntie-D]

It doesn't matter how small the lab - automation cuts down on human error. I've been where you are - if you want to message me for support feel free

[tricore]

Set up a schecule for procedure review by month. Review one 12th of the total number of procedures every month. That way they do not all have to reviewed in a short time.

AABB std 29th

6.1.4 Review of each policy,proces, and procedureshall be performed by an authorized individual at a minimum every 2 years.

CAP

**REVISED** 07/11/2011

COM.10100 Procedure Manual Review Phase II

There is documentation of review of all policies and procedures by the current laboratory

director or designee at least every two years.

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 1/24 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.

REFERENCES

1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments

of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407(e)(13)]

2) Borkowski A, et al. Intranet-based quality improvement documentation at the Veterans Affairs Maryland health care system. Mod. Pathol.

2001;14:1-5

COM.10300 Knowledge of Procedures Phase II

The laboratory has a system documenting that all personnel are knowledgeable about the

contents of procedure manuals (including changes) relevant to the scope of their testing

activities.

NOTE: The form of this system is at the discretion of the laboratory director. Annual procedure

sign-off by testing personnel is not specifically required.

Evidence of Compliance:

✓ Records indicating that the testing personnel have read the procedures, new and revised, OR

records of another documented method approved by the laboratory director

 

 

[aj2018]

Tricore thank you for referencing the regulations...

under the CAP one it says "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." 

 

what does it mean when it says " signature review must be the level of the each procedure or as multiple signatures on a listing of named procedures!!! 

 

thank you

[Likewine99]

I can understand why you might want to get rid of your ProVue but before it becomes a boat anchor, think about any labor savings you may have with it there.  The ability of having a generalist load it and not have to babysit with it while covering other depts, less chance of error labeling cards, those kind of things.

 

Put ditching the PV lower on your priority list, and no I do not work for the vendor 

 

CAP regs are a great place to start.  Work on this in small chunks, the whole thing is very overwhelming the first time out.  Hit the easy stuff first, daily maint records, monthly PM stuff.  Get your staff involved, they have a stake in this too.

 

Keep posting here, lots of good information sharing happens here.

 

Feel free to message me too, I have been where you are and you will make it!

[aj2018]

Thank you. I'm taking it all piece by piece.  I'm about to start on the paper work that needs to be sent to AABB for the upcoming inspection that we think might happen in January.  

next on the list are all the PMs for the equipment and all the checks.  

One thing I'm confused a little about is the correlation study that needs to be done for CAP..how it should be done since we do testing in tube, manual gel and the ProVue.

I know we keep patient antibody IDs indefinitely, but all the daily and weekly reports that get generated overnight from the LIS, I either need to find a place to store it or maybe come up with a table or form to document review day by day or week by week and discard them.  Also, im not sure if blood issue paperwork needs to be kept.  they apparently put a copy in the patient's chart and we keep a copy!!! 

Also blood supplier paperwork, im thinking after reconciling the billing every month that can be discarded like blood return slips..etc.. 

[tbostock]

Check out the record retention regs in the AABB Standards before deciding to throw anything away.  We are required to keep most records for 10 years in NY State, and indefinitely for some things.  So be careful there.  If in doubt, DON'T throw it out.  I keep blood center invoices forever; it may the only way to solve a dispute if they say you received a unit as part of a lookback, and your records show that you did not receive that unit.

 

For manual review, the Medical Director or designee must review and sign each procedure.  We have a statement on a cover sheet in each manual that he has designated me as the designee to review and sign each.  The cover sheet has the list of SOPs with the revision dates.  He signs each individual SOP only when there is a change made.  There is no requirement for the techs to sign anything annually.

 

Method correlations: we do them every 6 months, for each test and each method.  So we check blood types by tube and solid phase, antibody screens by solid phase, gel, LISS and PeG, etc.  5 samples for each with at least one positive.

[Eagle Eye]

for correlation: take two specimen one positive and one negative screen.

Run all tests using all methodology ABORH, antibody screen, panel.....Only test you run by those technique

[Mabel Adams]

The Joint Commission says that someone qualified under CLIA as a "Technical Supervisor" must do the bi-annual procedure review and for Blood Bank this must be an MD.  If you are not inspected by JC you can be the designee and meet AABB requirements.

[COTTONBALL]

Hi Mabel,

 

when you say "if you are not inspected by JC..." do you mean the lab or the organization?  The reason I am asking(naively) is because I have never had a JC inspector visit the Transfusion Service department at the JC-inspected hospitals where I have worked in the past.  

 

Regards,

 

Connie

[AMcCord]

I can understand why you might want to get rid of your ProVue but before it becomes a boat anchor, think about any labor savings you may have with it there.  The ability of having a generalist load it and not have to babysit with it while covering other depts, less chance of error labeling cards, those kind of things.

 

Put ditching the PV lower on your priority list, and no I do not work for the vendor 

 

CAP regs are a great place to start.  Work on this in small chunks, the whole thing is very overwhelming the first time out.  Hit the easy stuff first, daily maint records, monthly PM stuff.  Get your staff involved, they have a stake in this too.

 

Keep posting here, lots of good information sharing happens here.

 

Feel free to message me too, I have been where you are and you will make it!

 

I strongly agree about holding off on dumping the instrumentation. When you have generalists working, the automation standardizes interpretation of results and saves them a lot of time. On evenings and nights they can be stretched very thin. Automation in blood bank can help tame their workload and prevent serious errors. It's not just for 'big' labs. Comparison studies don't have to be a huge ordeal. You've received some good recommendations for how to tackle those. (And no, I don't have a ProVue, but I am a smaller lab with automation and lots of generalists.)

 

I also agree strongly with those who say you need to keep yourself well organized. It will make your inspections much less stressful. The inspection book is an excellent suggestion. I've kept one for quite a few years. Set up a 3 column table or spreadsheet for yourself that lists each checklist item. Use the second column for a short explanation of how you meet the requirement. Use the third column to note where necessary documentation is found. You won't necessarily need to fill in all 3 columns for all the checklist items. Put this in the front of your inspection notebook. The table/spreadsheet can help you stay cool and collected during your inspection. If you happen to be gone that day, someone else can cover the inspection and find the necessary information more easily. It will take some work to set up the first time, but updates quickly after the first time. Media Lab offers a product online called Inspection Proof that will serve the same purpose with some additional features that are very helpful - doesn't cost very much. We are just getting started on it and think it will be great.

 

You may feel overwhelmed at first, but once you get yourself organized all you will need to do is update things as you go. It gets better after that.  Good luck!

[L106]

Hi Mabel,

 

when you say "if you are not inspected by JC..." do you mean the lab or the organization?  The reason I am asking(naively) is because I have never had a JC inspector visit the Transfusion Service department at the JC-inspected hospitals where I have worked in the past.  

 

Regards,

 

Connie

 

I'm sure she meant that the organization is inspected by the Joint Commission.  What you said is true.....we never used to see the JC inspector come to the Lab.  (I always suspected that if the Transfusion Service was CAP and/or AABB accredited, JC felt comfortable and didn't want to waste time there.)

 

However, now the JC inspectors take more of an inspection approach of selecting a patient case and following it all the way through from admisstion to discharge.  So if the case happened to involve transfusions, you are now more likely to have the JC inspector come down to the Transfusion Service and ask questions, etc.

 

Regardless of whether the JC inspector comes to the Transfusion Service, if your instituation is JC accredited, you are obligated to abide by their standards that pertain to the Transusion Service.

 

Donna

[L106]

Hi Mabel,

 

when you say "if you are not inspected by JC..." do you mean the lab or the organization?  The reason I am asking(naively) is because I have never had a JC inspector visit the Transfusion Service department at the JC-inspected hospitals where I have worked in the past.  

 

Regards,

 

Connie

 

I'm sure she meant that the organization is inspected by the Joint Commission.  What you said is true.....we never used to see the JC inspector come to the Lab.  (I always suspected that if the Transfusion Service was CAP and/or AABB accredited, JC felt comfortable and didn't want to waste time there.)

 

However, now the JC inspectors take more of an inspection approach of selecting a patient case and following it all the way through from admisstion to discharge.  So if the case happened to involve transfusions, you are now more likely to have the JC inspector come down to the Transfusion Service and ask questions, etc.

 

Regardless of whether the JC inspector comes to the Transfusion Service, if your instituation is JC accredited, you are obligated to abide by their standards that pertain to the Transusion Service.

 

Donna

[AMcCord]

We almost always get a brief visit in the lab from the JC inspector. We are CAP inspected - CAP is deemed for JC (ditto for AABB I think) so their findings are accepted by the JC. 

 

Pathology always gets to talk with them about tissue handling, reporting, etc. though it's not a long visit. They almost always stop by blood bank briefly with a few questions on whatever their main focus is for that inspection cycle. We've had to explain our process for handling autologous blood, for collection of blood bank specimens, for issuing blood products - not all in the same inspection, however. Nothing difficult. This year I expected them to ask about what we were doing to ensure that the right patient gets the right product, but I never even saw them. They visited micro instead. And I have a new process in place for patient ID that they would have loved - darn!

[tbostock]

The sign of a good Blood Banker: bummed that you didn't get to speak to inspectors. 

 

 

We almost always get a brief visit in the lab from the JC inspector. We are CAP inspected - CAP is deemed for JC (ditto for AABB I think) so their findings are accepted by the JC. 

 

Pathology always gets to talk with them about tissue handling, reporting, etc. though it's not a long visit. They almost always stop by blood bank briefly with a few questions on whatever their main focus is for that inspection cycle. We've had to explain our process for handling autologous blood, for collection of blood bank specimens, for issuing blood products - not all in the same inspection, however. Nothing difficult. This year I expected them to ask about what we were doing to ensure that the right patient gets the right product, but I never even saw them. They visited micro instead. And I have a new process in place for patient ID that they would have loved - darn!

[aafrin]

i agree 100% with you Terri.

[amym1586]

Just got assigned with an assessment team!

 

So nervous!

[Malcolm Needs ☆]

The impression you give me on here suggests that you will do fine!