adiescast Posted January 11, 2012 Share Posted January 11, 2012 I am doing a self inspection with the 7/11/11 revision of the checklist and came across this statement in the note: "All tests that include an interpretation must be reviewed by the laboratory director or qualified designee before release from the laboratory."In my opinion, all tests in blood bank include an interpretation. Does this mean that everything must be reviewed before they can be released? Has anybody figured this one out already?Thanks! Link to comment Share on other sites More sharing options...
EMB4879 Posted January 11, 2012 Share Posted January 11, 2012 I noticed that too and we are in our inspection window. My question is who is a qualified designee?? I review our daily QA failures and panels and my counterpart reviews a daily grid report....are we qualified?? We do have "automatic traps" for improbable results, however the techs review this then release the results. I think we are going to just leave it at that...there would be no way the pathologist could review all results before being released, even our antibodies would not be able to be reviewed in a timely manner. Link to comment Share on other sites More sharing options...
webersl Posted January 11, 2012 Share Posted January 11, 2012 I interpret "qualified designee" to be the technologist. Do we agree that a Medical Technologist is qualified to interpret ABORh results, panel results, etc.? I say that the course work they took, the exams they took, and the PT they regularly perform proves that they are "qualified" to interpret the results. I would contrast this with the following situation: a non-med tech (high school educated, for example) is performing immunohematology testing. They could not report final interpretations alone - they need someone qualified, like a med tech, to release the results. Link to comment Share on other sites More sharing options...
Mary** Posted January 11, 2012 Share Posted January 11, 2012 I do the same. I totally agree with you webersl. We were recently inspected and didn't have an issue with this. Link to comment Share on other sites More sharing options...
Likewine99 Posted January 12, 2012 Share Posted January 12, 2012 You can outline in your QC/QA policy and procedure what your lab consideres a "designee". If you have a computerized BB system your truth tables and error flags provide a level of electronic review which can be utilized to assist your techs/designees in releasing results from the lab.Then throw in a blurb outlining that anything "unusual" or "suspect" is reviewed by the lab director prior to release from the lab, with the ultimate goal of providing timely, accurate results to the physicians.I think you can fufill this reg with the proper wording and you are on the right track with you and your counterpart doing daily review. Make sure at inspection time you are doing what your p&p say you are doing. Good Luck:) Link to comment Share on other sites More sharing options...
COTTONBALL Posted October 13, 2014 Share Posted October 13, 2014 :cries:HELP! I am wondering if you all will update me on current standards or best practices in reference to a process for Blood Bank work review. I manage 30 techs (most are generalist) and have been performing daily reviews of their work. Along with review of Meditech exception reports and override reports I find lots of errors, as you can imagine the deviations and FDA/CBER reports are plentiful. This fast-paced level II trauma center needs fast-paced competent techs. I have been in the business for 25 yrs (only 18 months here). Turnover rates and rushed training sessions (two weeks) contribute to substandard lab practices. The problem is a Director who does not understand Transfusion Medicine and the potential harm we can bring to our patients (he only sees numbers). If I could list the errors here, you may also lose sleep tonight. :angered:He called CAP and asked if we needed to review 100% results. He wants to change to reviewing only 5% daily . To me this is unethical, unsafe and an accident waiting to happen. I am seriously concerned for the patients, so I turned in my resignation. All input, comments, and suggestions welcomed. No spell checks please. Sincerely, Cottonball, MT (ASCP)SBB goodchild 1 Link to comment Share on other sites More sharing options...
tbostock Posted October 13, 2014 Share Posted October 13, 2014 Cottonball, you have serious patient safety concerns that probably should be reported to regulatory agencies (CAP, State Dept of Health, or Joint Commission...whoever accredits your lab). However, although reporting is confidential and according to most corporate compliance protocols, you cannot be punished, this ends up (very sadly) being a big "bridge burner". In this case, I agree that a resignation is probably the best bet. Give the proper notice, maintain your high standards, don't burn any bridges on the way out. You never know who knows who in this field, and you might need a good reference someday. With your SBB credentials you will have no problem finding a position that will be more fulfilling. L106, COTTONBALL, David Saikin and 2 others 5 Link to comment Share on other sites More sharing options...
goodchild Posted October 13, 2014 Share Posted October 13, 2014 Admin director or lab director? Get your medical director to advocate with you for patient safety. What about the internal lab or hospital QA/patient safety/risk management department? Discuss your concerns with them to advocate with you for patient safety. Good luck! COTTONBALL 1 Link to comment Share on other sites More sharing options...
David Saikin Posted October 13, 2014 Share Posted October 13, 2014 WOW!! I think you did the right thing professionally. As stated above, don't burn your bridges. Are they hoping that if you only review 5% of the results the error rate will decrease? It won't really but will look better on paper - until you have a sentinel event. If you have enought Biologic Product Deviations I wouldn't be surprised if the FDA shows up . . . maybe that's what your director needs. A really thorough investigation . . . Good luck to you. COTTONBALL and Linda0623 2 Link to comment Share on other sites More sharing options...
Dansket Posted October 13, 2014 Share Posted October 13, 2014 I am wondering if you all will update me on current standards or best practices in reference to a process for Blood Bank work review. I manage 30 techs (most are generalist) and have been performing daily reviews of their work. Along with review of Meditech exception reports and override reports I find lots of errors,as you can imagine the deviations and FDA/CBER reports are plentiful. This fast-paced level II trauma center needs fast-paced competent techs. Sincerely,Cottonball, MT (ASCP)SBBMeditech is the most effective tool that I have to manage a group of Generalists. Every process is done in Meditech, I do not have any log books of any kind. Do you have control of the BBK module or does IT control it? Have you implemented the computer crossmatch? Doing so has a huge impact on eliminating low-value processes and stream-lining your operation.PM me if you want to know more. Link to comment Share on other sites More sharing options...
COTTONBALL Posted October 13, 2014 Share Posted October 13, 2014 Thanks so much for the input, but they are years away from computer crossmatching. They are hardworking, intelligent techs who have been short-changed for quite some time now. They don't know, what they don't know. I worked so hard with them these past 18 months, and they were actually beginning to like and appreciate my position on quality, and giving our patients the very best experience possible. I pray the buy-in sticks with them. This is the first for-profit organization I have worked for in my 25 years, and what a difference. Nursing is big on quality and for the most part knows the state of the lab. I have resigned my position on principle, and really hated leaving my wonderful coworkers. My core values in always doing the right thing, especially for patients well-being, I cannot trade in. I reported my concerns to upper management before leaving. Have two job offers already, but will take the next few weeks to get some sleep and hopefully grow some hair back Regards, Connie Linda0623, L106 and Malcolm Needs 3 Link to comment Share on other sites More sharing options...
COTTONBALL Posted October 13, 2014 Share Posted October 13, 2014 How can we move to computer crossmatch when the ABORH confirmation sample was drawn at the same time of the T&C sample (rainbow). Example: Both samples type as APOS. Patient receives APOS computer crossmatch or serological crossmatch (irrelevant). Patient receives APOS= trxn= post sample= (OPOS). Written policy states ABORH confirmation sample has to be drawn at separate time by a different drawer. A supervisor, not my techs, pulled the confirmation sample in a hurry .Now I am bald and fat. Regards, Connie Malcolm Needs 1 Link to comment Share on other sites More sharing options...
COTTONBALL Posted October 13, 2014 Share Posted October 13, 2014 Lab director. Medical director is not heavily involved on clinical side. I advised the seasoned blood bankers to make sure he knows it is unethical for lab director to require only 5% review when lab director knows there have been many near-misses and serious potential for harm to the patient. Thanks,Connie Malcolm Needs 1 Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted October 14, 2014 Share Posted October 14, 2014 Connie, I have huge respect for you over this. I think you are absolutely correct to stand by your principles. tbostock, AMcCord, COTTONBALL and 2 others 5 Link to comment Share on other sites More sharing options...
goodchild Posted October 14, 2014 Share Posted October 14, 2014 Standing by your principles is hard enough, but when it impacts your family's income it has to be a very difficult choice to make. I applaud you. COTTONBALL, galvania, Abraham and 1 other 4 Link to comment Share on other sites More sharing options...
Dr. Pepper Posted October 14, 2014 Share Posted October 14, 2014 I join the others in applauding what had to have been a very tough decision. Linda0623, AMcCord, COTTONBALL and 1 other 4 Link to comment Share on other sites More sharing options...
L106 Posted October 14, 2014 Share Posted October 14, 2014 How can we move to computer crossmatch when the ABORH confirmation sample was drawn at the same time of the T&C sample (rainbow). Example: Both samples type as APOS. Patient receives APOS computer crossmatch or serological crossmatch (irrelevant). Patient receives APOS= trxn= post sample= (OPOS). Written policy states ABORH confirmation sample has to be drawn at separate time by a different drawer. A supervisor, not my techs, pulled the confirmation sample in a hurry .Now I am bald and fat. Regards, Connie As the younger generation would say: "OMG!" (I don't think I want to hear any more of the horror stories!) As several others have said, I respect and congratulate you on your professional ethics. I'm sure that was not a pleasant decision to tackle, but I bet you never regret it. Glad that you already have a couple leads on a new job. Good luck! Donna COTTONBALL and Linda0623 2 Link to comment Share on other sites More sharing options...
Eoin Posted October 15, 2014 Share Posted October 15, 2014 I agree with the others. This takes some courage to stand by your principles. Spell it out to them if you gat an exit interview. I can only say how much I admire you for your stance. I am sure that you will not regret it. I hope that there is a close by employer who values your stand. All the very best. CheersEoin COTTONBALL and Linda0623 2 Link to comment Share on other sites More sharing options...
COTTONBALL Posted October 15, 2014 Share Posted October 15, 2014 Thanks guys. Your support means everything. I accepted a Blood Bank manager position at a well-known hospital and University. I will continue seeking your support and guidance, as this forum is the great gift that keeps on giving. My 2015 pledge is to be more visible here instead of behind the scenes. I look forward to breaking the Christmas bulbs again. Please,Please bring them back Respectfully, Connie L106, Eagle Eye, Sandy L and 3 others 6 Link to comment Share on other sites More sharing options...
Eagle Eye Posted October 15, 2014 Share Posted October 15, 2014 Congrats and Good Luck!! COTTONBALL 1 Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted October 15, 2014 Share Posted October 15, 2014 I second that Eagle Eye. COTTONBALL 1 Link to comment Share on other sites More sharing options...
aafrin Posted October 16, 2014 Share Posted October 16, 2014 Cottonball, All the best in your new job. COTTONBALL 1 Link to comment Share on other sites More sharing options...
Eoin Posted October 17, 2014 Share Posted October 17, 2014 Great News! All the best Connie. i will look forward to your posts.CheersEoin COTTONBALL 1 Link to comment Share on other sites More sharing options...
Karrieb61 Posted October 20, 2014 Share Posted October 20, 2014 My congrats also! Bravery is not always appreciated. Your new hospital is lucky to have you and my heart goes out to those in your former hospital who cannot bail out of what is a sentinel event just waiting to happen. Sandy L, COTTONBALL and Malcolm Needs 3 Link to comment Share on other sites More sharing options...
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