How many mistakes is acceptable?

[bronxbomber]

First of all I am new here, and if this is in the wrong thread I am sorry. We are having repeated problems with a blood bank tech. She keeps making mistake after mistake and they seem to be getting worse. We work for a supervisor and a lab manager that do not know blood bank. The major problems started in July of this year. This tech missed 4-5 antibodies in a short period of time. She has also handed out the wrong unit of blood on two occasions. She also falsified patient results at one point. These problems kept compounding on each other and our supervisor seemed to be doing nothing to fix the problems. After taking the matter to HR the tech was "retrained" and given a day off of work. Our supervisor that knows nothing about blood bank was retraining her. She has made minor mistakes on a daily basis since her retraining in December, but she has avoided most antibodies that came to the door.

This week she comes receives a specimen with no antibody history. She orders screened units from the reference lab and tells evening shift that the patient has an anti-E and anti-Fyb. She also said that the patient phenotyped positive for c. When the evening shift tech received the screened units and crossmatched them one of the was weakly incompatible. The tech reviewed the panel and she had marked c off on one heterozygous cell and the positive antigen typing. The tech repeated the antigen typing and it was negative. The patient clearly has an anti-c other than 1 heterozygous cell. The situation is brought to the supervisor and she has the tech that made the mistake change her results to match the evening tech's results and left it at that.

Is there anything that we can do to stop this tech before she harms somebody? Another tech that made a couple mistakes was moved to another department after just 2 very minor mistakes. Something needs done, but there isn't anyone in the hospital that knows blood bank enough to understand the severity of the mistakes. The tech is too busy texting, talking on the phone, and smoking to pay attention to her work. Even if she paid full attention to her work she is still going to make mistakes. Please, any advise would be appreciated.

[Malcolm Needs ☆]

It sounds to me like you have a major, major problem that could easily end in a fatality.

The nub of the problem seems to be the attitude and inability of the senior laboratory management staff to cope with the situation.

What can you do in such a situation?

The only thing I can think of off the top of my head sounds rather unpleasant for you, and may put you in an invidious position, but....

You must document each and every mistake this person makes, however small, and, for the sake of equity, so that she cannot claim bias, each and every mistake every other person makes, however small, including your own., and get each of them to sign this record.

If they refuse to sign, then a witness can sign to show that the record is genuine.

This documentation should then be shown to the senior laboratory management and HR, and copies sent to your clinical director and the board - they, after all, would also be involved in any litigation that may result in negligence. If necessary, and if there is still no movement, I would be inclined to get your professional body involved (indeed, this might be a good idea from the outset, because they will have legal teams that would be able to advise you about "covering your own back).

Mistakes will always be made in a laboratory. I never believe anyone who says they have never made a mistake, and they are usually the ones that eventually cause a major incident, but repeated mistakes, falsifying results, changing results after the event, etc, is nothing less than fraudulence and will put all her other co-workers' careers in danger. As she has already been re-trained, and is still making these mistakes, HR must be duty bound to start disciplinary procedures.

:mad::mad::mad::mad::mad:

[SRMC BB]

Is your BB medical Director aware of the problems?

Do you have a corporate compliance hot line where you could report things anon? Are you AABB accrediated? You can report things to them or FDA or Joint Commission and be protected under the Whistleblowers policy. There are also greviance policies where you will not get in trouble for reporting these types of things--you are putting the safety of the patients 1st!!!

You could also report things to your administrative representative (who your lab manager reports too) . I think they would be obligated to follow up on things to make sure action is taken.

Good luck and I hope things work out quickly.

Natalie

[tricore]

Does your institution have a Risk Management Department? That may be the place to go. If a patient is harmed it will be administration who is held responsible. In the instances where the incorrect product was issued, have these Biologic Product Deviations been reported to FDA? It is a legal requirement.

[bronxbomber]

We have reported it repeatedly to the lab manager, risk management, HR, called the corporate compliance hotline, and even followed the chain of command to the CEO of the hospital. I really am at a loss that they allow these mistakes to happen. I think the problem is that our immediate supervisor knows nothing of blood bank, and she tries to cover the mistakes up to a point. I don't know if this is because she doesn't know the severity of the mistakes, or if she does it for personal reasons. The tech making all the mistakes always blames them on someone else or just flat out denies that it was her work. I don't know how she can miss an antibody, turn out the wrong results, and sign her panel and still blame it on someone else. She blamed the last incident on the evening shift tech. She tried to say she told him to double check her Ag typing for c which is total crap. Even if she had told him to check it she shouldn't have turned out a result she wasn't 100% sure of or ordered screened units from the ARC reference lab. We are not AABB accredited anymore. We dropped them about 2.5 years ago. As far as I know nothing has been reported to the FDA. I do know in the case of her handing out the wrong unit of blood the nurse caught it at the bedside, so risk management said it wasn't a big issue (did this twice). To make things worse she handed out an A unit to a B patient on one, and the other patient had a E, c, and K and she handed out units from an unscreened patient. It's looking like reporting them to CAP, joint commission, or the FDA is about my only option. I don't care what situation it puts me in since I believe I am putting patient's lives first. We all make mistakes, but for as long as I have been there she's the only tech that's made a non-clerical error. Everyone puts the wrong armband number in the computer or scans the wrong specimen in every once in a while, but she makes these clerical errors daily with the major errors on top of them.

[David Saikin]

Keep a running file of the errors . . . document when you have gone to each level of management. When the shoe falls on this (and it will if nothing is done), you and your fellow techs don't want to take any heat. Your management group will try to spread the blame for what has and is transpiring . . . if you don't have any documentation, you won't have any defense. It seems you have exhausted all your channels EXCEPT calling your state health department/or you can call CAP if you are CAP certified - - - if you do that, you'd better have your documentation. No agency will listen to heresay, without dates - tiems - occurrences you will have nothing. Good luck!

[kate murphy]

What a hot seat you are in! My sympathies.

I agree that your organization does not seem responsive at all to a very serious problem.

I also agree that you need to document all the errors, and all the times you spoke with lab, risk management, HR, corporate compliance hotline, and even the CEO of the hospital - include names and dates and thier action/inaction.

I would suggest one final time talking to your lab management - show them the documentation and inform them that you feel you must take action to guard patient safety. I would highlight the A unit almost given to a B patient. Try to educate him/her that this would have been a fatality. If there still is no action, then call. CAP hotline, Dept of Public Health, or Joint Commission. I think you will get more action with CAP if your lab is a member. Please be brave. It's terribly difficult to stick your neck out, but some patient down the line may live because of you. Please post back if you need moral support, and let us know how it's going.

[Bill]

David offers excellent advice! If I correctly surmise your location from your name--you can send the documentation to the NYS Education Dept Office of Professions as a complaint against the tech's liscense. They will investigate her and can suspend or revoke the individual's liscense. The NYS Dept of Health Laboratory Evaluation Unit also has confidential complaint reporting section.

[Eagle Eye]

WHen the tech issued wrong unit, that should have been reported to FDA. Anytime blood bank release wrong unit it should be reported to FDA eventhough error was caught before transfusion. When she typed patient incorrectly, it was definetly reportable to FDA.

You must report to CAP, FDA and NY State Deparment of Health.

[tbostock]

Your Blood Bank Medical Director is ultimately responsible. Speak to him/her and document it.

[L106]

My comments:

David Saikin: Excellent advice!! Document, document, document (and then hope that you don't have to use it!)

Bill: If bronxbomber is working in NY, you advice is also very helpful.

aakupaku: I agree with you: I am also under the impression that "near-misses" (like issuing the wrong donor unit, even if it is not actually transfused) must be reported as a "deviation" to the FDA (for facilities in the USA, of course.)

Terri Bostock: With many pathologists now working as "corporations" (rather than hospital employees), I think it's debatable who is ultimately responsible, but I can assure you that an injured plaintiff would go after the "deep pockets" (ie: the hospital.) Well, actually, they would probably go after everybody involved.

[Deny Morlino]

Agreed L106. Perhaps a method of leverage with the management involved is to mention the HUGE litigation potential involved with the lack of responsibility being demonstrated by the tech. Who handles the re-training when needed? If it is the lab manager and this person does not have a good understanding of blood bank protocols, what qualifies this person to be the trainer? Who reviews the blood bank documentation, QA, etc.? It seems to me you are fighting a difficult battle ! Hang in there and stick to your guns!! Ethically and morally you seem to be well supported by the group here. I know I would have a hard time sleeping if I had not done everything I felt I could to prevent an error that could cost a patient's life. Best of luck with the dilemma.:cool:

[tbostock]

My comments:

Terri Bostock: With many pathologists now working as "corporations" (rather than hospital employees), I think it's debatable who is ultimately responsible, but I can assure you that an injured plaintiff would go after the "deep pockets" (ie: the hospital.) Well, actually, they would probably go after everybody involved.

Yes, I was assuming the same, that bronxbomber was from NYS, and the NYSDOH does hold the Medical Director responsible, contracted or not. He/she also has to sign off on the annual competency of staff, so if this person is not competent (sure seems like they are not) the Medical Director would be in the hot seat if there was a fatality. Lawsuit-wise, oh yeah...EVERYBODY is going down.

[L106]

Yep, I agree with you, Terry.

[velliott]

Would you by chance be an AABB accrediated blood bank? You can report quality issues to them. If you're not AABB isn't there a way to report issues?

[Dr. Pepper]

What a nightmare! I would find it hard myself to work in a place where no one, from the bad coworker to lab management to Risk to the CEO did not care about the situation. Everyone has offered excellent advice. I can only repeat their mantra: document, document, document. If no one cares internally, the CAP and your state board of health surely will.

And even if she denies them, your LIS should be able to provide an audit trail of some of the errors.

[rae221]

I would be interested to found out from blood bank supervisors what criteria is established in your laboratory or hospital that gives the supervisor guidelines for categorizing errors and what the nature of the follow-up should be. Is there a concrete standardized system for the supervisors in dealing with issues that come up. How many do you allow before they must have retraining? Do you prevent them from reporting results until the retraining happens? It seems like the system in place should be known to both supervisor and staff member. Everyone always wants to know what the expectations of the job are but what are the expectations if you make an error.

People are placed into supervisory positions who don't necessarily have management experience and tools are needed to guide them in dealing with these issues.

[Malcolm Needs ☆]

I would be interested to found out from blood bank supervisors what criteria is established in your laboratory or hospital that gives the supervisor guidelines for categorizing errors and what the nature of the follow-up should be. Is there a concrete standardized system for the supervisors in dealing with issues that come up. How many do you allow before they must have retraining? Do you prevent them from reporting results until the retraining happens? It seems like the system in place should be known to both supervisor and staff member. Everyone always wants to know what the expectations of the job are but what are the expectations if you make an error.

People are placed into supervisory positions who don't necessarily have management experience and tools are needed to guide them in dealing with these issues.

I agree almost entirely with what you have posted rae221 (particularly the last sentence), and, in an ideal world, everyone should know exactly where they stand. Unfortunately, it is not an ideal world. There are so many different ways that mistakes can be made in any laboratory, not just a Blood Transfusion Laboratory, that it would be all but impossible to list them all, and, therefore, impossible to put a "levy" on each one.

In addition, the consequences of the same mistake/slip/error made by one person in a particular circumstance may be extremely serious, even fatal, whilst the same mistake/slip/error made by a different person under different circumstances may have minor or no clinical sequalae.

With this in mind, the only suggestion that I can make is that the most senior person trained in the work of the laboratory (and that training is most important) is probably in the best position to both investigate the mistake/slip/error, and then decide upon what steps should be taken against the individual who made the mistake/slip/error. If the mistake/slip/error is thought to be of a nature serious enough (or, indeed, the person who made the mistake/slip/error was also the most serious person trained in the work of the laboratory) then someone of equal or higher standing should be brought in from another laboratory performing the same kind of work to undertake the investigation and decide whether disciplinary action/retraining/etc is appropriate.

I am certain that others will have differing views.

:confused::confused:

[rae221]

Thanks for your imput Malcom. What you say makes sense, although I think there has to be some consistency set.. Would you recommend submitting to the laboratory manager documentation of all variances that have occurred in the blood bank, regardless of FDA reportability? What would you think of a monthly report to the manager listing the nature of the variances and what corrective action was initially taken. If the manager wants more then they can get back to you and ask you for further follow up. This way the supervisor is not taking the sole responsibility for what happens in the department and the laboratory manager is fully informed and this is documented. If they don't respond back then this is documented also. Also, would you submit the FDA reportable issues to management and let them perform the root cause analysis using the supervisor as the resource for whatever information is needed? Then when they have finished and given you their report you can file this with the FDA. Do you think this process has validity and helps support the supervisor when policies are not too clear?

[Malcolm Needs ☆]

Thanks for your imput Malcom. What you say makes sense, although I think there has to be some consistency set.. Would you recommend submitting to the laboratory manager documentation of all variances that have occurred in the blood bank, regardless of FDA reportability? What would you think of a monthly report to the manager listing the nature of the variances and what corrective action was initially taken. If the manager wants more then they can get back to you and ask you for further follow up. This way the supervisor is not taking the sole responsibility for what happens in the department and the laboratory manager is fully informed and this is documented. If they don't respond back then this is documented also. Also, would you submit the FDA reportable issues to management and let them perform the root cause analysis using the supervisor as the resource for whatever information is needed? Then when they have finished and given you their report you can file this with the FDA. Do you think this process has validity and helps support the supervisor when policies are not too clear?

I would have no problem with what you suggest. In fact, to a certain extent this is already what happens in my own Laboratory. Obviously, working in the UK, we don't have the FDA, but we do have SHOT (Serious Hazards of Transfusion) and SABRE (Serious Adverse Blood Reactions and Events) to whom we report anything serious (or, if a near miss, potentially serious), but we also have something called NICARS (for the life of me, I cannot remember off the top of my head for what this acronym stands), which are small, inconsequential errors/mistakes/slips, which we record to ensure there is no trend.

:):)

[Dr. Pepper]

Very good question, rae221. As the lab cynics say, "What do you have to do to get fired around here?" Malcolm points out that there are a myriad of errors that can be made with a wide range of consequences, even for the same error. In our lab, we have an internal QA form which serves as an Access database entry form. One of the fields that is entered is a severity level. After much discussion, we settled on three levels: actual or potential patient compromise, no patient compromise but still a QA issue, and not a QA issue but you still want to document it. We tried to get a little more specific but were were unable to do so for the reasons discussed above.

That being said, any incident of any seriousness is discussed by me (the BB supervisor), our lab manager and our medical director. We give a verbal warning or written warnings. (These incidents generally warrent a written warning.) You can have a first, second, third or final written warning, after which the employee may be disciplined, which may range from suspension without pay to termination. Expectations for correct behaviour or job performance are clearly indicated at all stages, and training and reevaluation for competency done if indicated. This process is outlined to new hires and meshes with the hospital's corrective discipline policy. It may be somewhat subjective, but we try to treat all employees and incidents of a similar nature the same way. We have invested a lot of time and training in our staff, and would like to preserve these resources. Our goal is not punative, but rather to correct problems that need correcting and improve the work we put out and the service we provide to our customers. You don't have start the process at first warning (our hospital takes any patient misidentification issue, such as drawing the wrong patient or reporting out the wrong patient's results, to final written warning).

Most of our techs are very talented, trained and concientious, and very open to opportunities for self-improvement. You do, however, need to weed out the bad apples, a group to which the tech whose work problems started this thread would seem to belong. That's another tough question or two for managers: is this person beyound technical redemption or not? At what point do you say, enough's enough, it's not working out? Any what about the model employee who performs flawless work for decades but just happens to make a couple of very serious errors? What if he/she had been given a final warning but years have passed before a recurrance? Or a good employee who has made serious errors but has personal issues and may need some help from an employee assistance program? These are very hard issues to quantify and to caste in stone. Discussion with and assistance from human resources may be a big help.

[Malcolm Needs ☆]

Dr.Pepper, this seems an excellent scheme, but, as you say, what about the outliers? This was what I meant when I put it more clumsily than you.

:)

[kathL]

Going back to the original situation...oh my gosh. Working in the transfusion medicine field requires a certain level of accountibility. It sounds like all the regular channels to help improve the situation from the regular employee's part have been done. How frustrating.

Tracking and trending of even small oops! and near misses can really give a better picture how a department is running. It's too bad the big ones (like issuing incompatible blood) are being missed & swept under the table. Obviously this original situation presented is not doing well.

As an employee, I would leave if possible. Working for an employer that doesn't share the same morals of quality can be the wrong fit. Asking the employee to do another person's job (event reporting, tracking everyone's mistakes) can create a really negative work environment. I would leave lots of documentation on the exit interview.

[Dr. Pepper]

Malcolm, if by outliers you mean the workers, even the best ones, who are already down the progressive disciplinary path, I guess you should be consistent and treat the good ones and bads ones the same way. We have a tech, one of our students from a few years ago, who mixed 2 BB pre-op samples and reported out the other patient's blood type. Our checks and balances enabled detection of the errors when they were retyped, but he went to final warning status. He's an excellent tech and has done everything we've asked of him, but made these errors, and I would be very sad if it happened again and we had to let him go. I also think my management might look differently at errors made five years apart compared to five weeks apart. The ones you want to let go, with documentation and management support, that should be easy. Hopefully their shortcomings would show up in a initial probationary period making even easier to say farewell.

[Malcolm Needs ☆]

I also think my management might look differently at errors made five years apart compared to five weeks apart. The ones you want to let go, with documentation and management support, that should be easy. Hopefully their shortcomings would show up in a initial probationary period making even easier to say farewell.

I agree entirely with your post, especially the part I have quoted above.

:):)