Dry Labs!

[QJULI]

I have recently proven for the second time that an employee is 'dry lab' testing blood bank reagent QC. The second time also proved that he was not performing the unit retype either. My direct supervisor did not (to my knowledge) discipline this employee. IF he had a written warning the first time I guess I thought he would have been suspended or fired on the second offense. That has not happened. Does anyone have any suggestions on what to do? I have tried to contact my pathologist to see if he is fully aware. I have sent emails to the accrediting agencies to see if forging this record is illegal or just unethical. I am not getting communication back and I am really struggling. Thanks for all your suggestions.

[Auntie-D]

I don't understand what you mean by 'dry lab' testing reagent QC.

And what do you mean by unit retype? You mean confirming the unit's group? If so there isn't actually a requirement to do that if an immediate spin, tube crossmatch is done...

[Eagle Eye]

I don't understand what you mean by 'dry lab' testing reagent QC.

And what do you mean by unit retype? You mean confirming the unit's group? If so there isn't actually a requirement to do that if an immediate spin, tube crossmatch is done...

If you are in US and AABB accredited :

AABB std 5.12 Serologic Confirmation of Donor Blood ABO/Rh (including autologous units)

Before transfusion, the ABO group of each Whole Blood and Red Blood Cell component and the Rh type of such units labeled as Rh negative shall be confirmed by a serologic test from an integrally attached segment. Confirmatory testing for weak D is not required.

[Eagle Eye]

CAP TRM.40450 Donor Units ABO/RH Confirmation PhaseII

Records are available that document the confirmation of the ABO group of all red blood cell components and as appropriate, Rh type, using a sample of red cells from an attached segment.

[Auntie-D]

If you are in US and AABB accredited :

AABB std 5.12 Serologic Confirmation of Donor Blood ABO/Rh (including autologous units)

Before transfusion, the ABO group of each Whole Blood and Red Blood Cell component and the Rh type of such units labeled as Rh negative shall be confirmed by a serologic test from an integrally attached segment. Confirmatory testing for weak D is not required.

Ahh... In England packs are guaranteed and in Scotland they are prepared to the same standard, though not guaranteed. We just do an immediate spin, tube crossmatch to guarantee ABO compatibility.

Still don't understand what a 'dry lab' is though...

[Eagle Eye]

what I am thinking here is the tech is not performing QC and documenting results....if this is the meaning of DRY lab, this employee would not last in my lab after even first incident...if caught red handed!!!!

[Bill]

Did you ask your direct supervisor if there was any discipline? Without the answer to that, you are really putting yourself in a bad situation with your actions. The other thing to remember is that your "proof" may not be so according to Human Resources or Legal departments. Also, the employee is afforded "due process" before any action can be taken. Unfortunately, these items can take time--even frustrating the supervisor.

[Liz]

QJuli, Just inform your supervisor. It is not your fight to fight. But do inform the supervisor.

"Dry" hmmm that has actually a meaning in Labs that is quite different from yours.

[SMILLER]

Q Juli

You may want to stop posting things like this on a public forum, as it sounds like you have several violations here of federal regulations, involving not only a testing associate but also possibly supervisory as well.

Having shocked you (hopefully) with that, I would say that you need to go up the management chain with any complaint that invovles a corporate compliance issue like this.

This does not sound like something minor like a dress code violation: If you feel the immediate supervisor is not acting appropriately then you are obligated to take it further. Next to your administrative director and then his or her VP if necessary. As a last resort, at our hospital, we have a corporate compliance system that includes a system for reporting stuff like this (anonomously if you want to) that is outside the usual chain. You should have something like this. Good luck.

[MAGNUM]

I don't understand what you mean by 'dry lab' testing reagent QC.

We used to call this sink testing, where the testing is performed as the tech pours the sample down the sink.

[jeanne.wall]

Q Juli

I share your belief that this is wrong and that you need to step up and speak out. If your facility is AABB accredited you have the option of anonymously communicating concerns about quality or safety (the standard is listed below). The contact information is +1.301.215.6492 or accreditation@aabb.org. CAP has a similar program, and while I don’t know about other laboratory accrediting groups I’d expect that you will find a similar program. Good luck!

1.5 Communication of Concerns

The blood bank or transfusion service shall have a process for personnel to anonymously communicate concerns about quality or safety. Personnel shall be given the option to communicate such concerns either to their facility’s executive management, AABB or both. AABB’s contact information shall be readily available to all personnel. Standards 6.1.5 Standard 9.1 apply.

[Mabel Adams]

Possibly, the HR wheels are working but due to confidentiality laws they can't tell you what action is being taken. Your supervisor should be able to reassure you that s/he 'gets' the seriousness of the charges and the organization has a system to deal with such cases.

[Liz]

I see that you are the supervisor so you can take action openly or keep it anonymous.

And in other parts of the world the standard applies as well:

EU Directives

During 2006, the EU Directive 2002/98/EC and Commission Directive 2005/61/EC came into force making reporting of serious adverse reactions and events relating to the quality and safety of blood components mandatory.

Reporting is based on a confidential anonymous system.

All blood and blood products must be traceable from donor to recipient. This information must be available for thirty years. Therefore, we have a professional responsibility and a legal obligation to adhere to these statutory requirements.

[AMcCord]

Both issues are a mandatory report to CBER under Biological Product Deviation reporting standards.

[Eoin]

Heard of Dry Pubs in Australia, but never dry labs.

I presume this means that the perpertrator of these acts is willing and knowlingly going outside laid down procedures (i.e. not performing required testing). Here he/she would be up before the professional body so fast his/her feet wouldn't touch the ground. Also your organisation should take immediate action.

Any other comments I would have are unprintable. People like this we can well do without. As far as I am concerned this is a criminal negligance case.

I do agree, you should be careful discussing it on an open forum however, as the perpertrator (won't use the word worker) does unfortunately have statutory legal rights as well.

Cheers

Eoin

[John C. Staley]

QJuli, my first question is, where do you fit on the food chain? Are you a peer of the offender or a supervisor? That makes a difference on the route you take. Second, is your proof something that will stand up or would it just be your word against theirs? Make sure you have reliable proof.

I realize this is very frustrating and disconcerting for you. In any lab I've been in this is one of the few grounds for immediate dismisal. It's not a big step for falsifying QC records to doing the same for patient testing.

Good luck and I hope you are successful in getting this practice stopped. We don't need people like that in the labs.

[Liz]

I have recently proven for the second time that an employee is 'dry lab' testing blood bank reagent QC. The second time also proved that he was not performing the unit retype either. My direct supervisor did not (to my knowledge) discipline this employee. IF he had a written warning the first time I guess I thought he would have been suspended or fired on the second offense. That has not happened. Does anyone have any suggestions on what to do? I have tried to contact my pathologist to see if he is fully aware. I have sent emails to the accrediting agencies to see if forging this record is illegal or just unethical. I am not getting communication back and I am really struggling. Thanks for all your suggestions.

I reread your post. The person did not retype the unit; I don’t see what else you are waiting for. For the sake of the patients you must take action but keep yourself safe. See the Pathologist or person in charge who you trust rather than sending emails and letters, if you do not have the authority do not document anything until asked to by a person that you trust (I repeat). If you have proof as you say then go straight to a person in authority, make sure that it’s not just hearsay (unconfirmed report).

[adiescast]

If you are this person's peer, you will not be privy to the actual actions your organization is taking with them. Talk with your supervisor about your concern that it is not being handled, but don't expect to hear what they did exactly. Look for concern about the seriousness of the situation and assurances that it will be dealt with, then watch for changes. Assuming that you have proof of this problem, have provided the proof to your supervisor and to others up the management chain, and have not gotten assurances that they view it as serious and will take care of it, ALL of the accrediting agencies have phone numbers for reporting. An earlier poster gave the AABB Standard. CAP, TJC, and COLA have numbers. CMS and FDA have numbers. Don't blow the whistle until you are certain that your institution is not handling it, but definitely do it after you are certain. Patient's lives are at stake.

Your lab should have information available to you for this reporting with their accrediting bodies. All of them require their accredited labs to provide this information to their employees.

Edited November 18, 2011 by adiescast
Added last line

[QJULI]

Well it only got worse!! My lab manager threw me under the bus. He denied any previous knowledge or accusations against the 'dry' employee to the pathologist and made me look like a vindictive, troublemaker. I did manage to set the record straight with the pathologist who is not stupid, knows he was lied to, and is not happy. SO. . .now do I go to hospital administration and tell them that PATIENT SAFETY is not at the top of the list in the laboratory?? Isn't my lab manager, who lied to protect the 'dry' employee JUST AS GUILTY as the employee who was actually fudging the records??

Nothing FDA reportable, nothing left the lab. . .this time.

Still working on CLIA and JCAHO angle. I don't want to lose my job. I am safety minded!! This is a horrible stressful situation. IF I go to hospital administration and it all comes out with my boss. . .. how much more miserable will my job be?? I just keep weighing my choices and looking for guidance and suggestions.

Thanks for all the posts!!

[Liz]

My honest caring advice, since you have no proof, is hold on to your job. The ethics that you live by are commendable. But take care of yourself and your livelihood.

[Auntie-D]

My honest caring advice, since you have no proof, is hold on to your job. The ethics that you live by are commendable. But take care of yourself and your livelihood.

Fully agree with this - if you lose your job who is going to keep an eye on them? You have done your bit - you have reported it. It will all come out in the wash eventually

[Malcolm Needs ☆]

The other thing is, why should the innocent lose their position, whilst the guilty keep theirs.

[Deny Morlino]

While I do not disagree with the points made by Liz, Auntie-D, and Malcolm, I do have another angle to look at this from. I am not sure what the employment opportunities are in your area, or how mobile you care to be. Ask yourself the question as to how difficult will it be for you to work with the guilty party and the supervisor? Only you can make that decision for yourself. Is the stress of the situation likely to cause you issues. If any of this is answered yes, you may want to consider employment at a different place if only for peace of mind.

[SMILLER]

QJULI

I want you to know how appreciative we are for your dedication to the profession in pursuing this. You have already gone above and beyond what most people would have done in this situation. Your concern over patient safety -- regardless of your own problems in trying to rectify the situation -- shows a high standard of ethical conduct that we can all be inspired by.

Once again, I urge you to try to find out what passes for a compliance officer in your facility. You may want to call your Risk Management dept for this information, sometimes an employee there will be designated as the CO. There has to be someone you can approach, not in the usual chain of command, that can help you at this point. You need to find protection for yourself as a whistleblower in addition to making sure the problem is being corrected, and this is exactly what a CO is supposed to do.

In my facility I would not mess around too much with our pathologist--this is an administrative issue and with all you've already gone through you need to try to get physicians tied up in this if you can avoid it.

Good luck, and thanks again.

Scott

[Mabel Adams]

I applaud your ethics but you must have a realistic vision of how things may play out. I hope it wouldn't apply in your case but I have read that, even with whistleblower laws, many whistleblowers pay a high professional and/or personal price for it.