AMcCord Posted June 8, 2010 Share Posted June 8, 2010 We were sited by a CLIA inspection for not doing direct observation competency assessment. The inspector told us that we had to assess the 'major' procedures/processes annually. In Blood Bank, at least, you can incorporate a lot of 'major' procedures/processes into one observation exercise - one crossmatch w/ antibody can include blood type, antibody dectection, antibody ID, antigen typing, crossmatching immediate spin and AHG, correct donor selection process, tagging, and checkout, equipment (centrifuge, cell washer, ProVue or Echo or whatever, etc) -takes a long time but covers a lot of ground. Link to comment Share on other sites More sharing options...
AMcCord Posted June 8, 2010 Share Posted June 8, 2010 ^^Awww, we all love you, Malcolm! LOL! We could always start a game thread of sorts where you have to answer the blood bank question the person above you posted, then leave one for the next person that posts after you--could be fun and I know I'd have to most likely do research at times and look stuff up to be able to answer some things, since I'm currently dusting off the cobwebs in the Blood Bank sector of my brain!!Fun idea actually! Link to comment Share on other sites More sharing options...
jcdayaz Posted June 8, 2010 Share Posted June 8, 2010 Brenda,Every Technologist has an annual "Competency File" that we keep in a separate filing cabinet. Each department of the laboratory has it's own specialized check-off list. All the departments a Tech works in they are obligated to keep this check list done. We document through the year when we perform each procedure and we have a direct observer. Both must sign the list--Tech and the direct observer.We also have many (too many, in my opinion) annual computerized tests that everyone must complete before their annual evaluation. If you don't have your competencies complete and ALL of your computer tests complete, you can't schedule your annual evaluation. No evaluation=no raise! Money is always a motivating force. Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted June 8, 2010 Share Posted June 8, 2010 ^^Awww, we all love you, Malcolm! LOL! We could always start a game thread of sorts where you have to answer the blood bank question the person above you posted, then leave one for the next person that posts after you--could be fun and I know I'd have to most likely do research at times and look stuff up to be able to answer some things, since I'm currently dusting off the cobwebs in the Blood Bank sector of my brain!!Brilliant idea! You go first, then you won't have to answer for a while!:D:D:D:D Link to comment Share on other sites More sharing options...
Dr. Pepper Posted June 8, 2010 Share Posted June 8, 2010 I agree that CAP would like you to sign off on new and revised P&P but does not require annual review and signing. (Our signoff sheets parrot back the CAP item # TRM.31190I verbiage). Brenda, you are right that annual review is not a bad thing if, as you say, they actually do it. That's the hard part, and it's a lot of info, often tedious, to go over.I have one wonderful core blood banker who knows it all, and 15 other generalists of varying degrees of wonder and BB experience. What I find useful for annual competency review is to include, among other things,the following:1. Pet peeves of mine (such as "writing over" incorrect log entries instead of drawing a line through it and dating and initialing. After the competency no one can say, "I didn't know...")2. Issues not generally encountered on a daily basis (such as P&P on maintaining blood services if the lab has to be evacuated, disaster plans, etc.).3. Issues and "what if" scenarios where you suspect everyone might not be on the same page.3. Opportunities for education, such as interpreting both a standard panel and an enzyme panel to remind techs which antigens are enzyme-labile, or having questions like "How many units should you have to screen to find 4 that are negative for E, K, Fya and S, and in what order would you use the antisera?" Educational info from the Principle sections of the P&P can be included as well.4. "Scavanger hunts" through the procedure manuals. If they can't find what they need to find, then I haven't done a good enough job making it easy to do so. It's also a great way to find and correct ambiguous, misleading or outdated material in the manuals.5. A few joke questions and silly pictures (the internet is a very rich source of zany pictures).I also ask my core BBer and the top 2nd and 3rd shifters if they have any issues they would like addressed. As a manager you can't see everything that happens, and if you're not routinely on the bench you don't have the point of view of a front-liner.Award a few modest raffle items (vendor pens and other swag, hospital coffee mugs, Doncan Donut cards, etc.).Along with the written exercise, we also do direct observation and occassional wet exercises. We are licensed in our state and require continuing ed; I award an hour CEU for the competency (the carrot on the end of the stick). Link to comment Share on other sites More sharing options...
L106 Posted June 8, 2010 Share Posted June 8, 2010 jcdayaz -Unfortunately, many on this site have stated that their institutions are not giving raises, some haven't for the last several years. (Yet, it doesn't seem right to complain about it when you look around at all the people who have lost their jobs, does it?) Link to comment Share on other sites More sharing options...
Brenda K Hutson Posted June 8, 2010 Author Share Posted June 8, 2010 Brenda--try this website:http://www.medtraining.org/corpsite/Where I work, we use this for twice per year competencies in all areas of the lab. They offer online quizzes that you can take and have good reading material to go along with the quizzes in each department. There's a lot on there for Blood Bank, too!Or you could just give all your employees passwords to this forum, and start a new thread called "Stump Malcolm" where they have to go head to head with him and see if they can beat him at a "Jeopardy" style, 20-questions sort of thing!!! LOL LOL!!Our Lab actually subscribes to that for CLS to use for CEUs if they want to (we are required in our State to get 24 CEUs every 2 years). I have found them (at least the Blood Bank topics) to be fairly simplistic. Also, I guess more of what I am looking for is in reference to staff knowing "our Policies and Protocols" really well. But I DO appreciate the input. Perhaps I will look at them again and see if I can make use of them in any way.I also have the freedom to bring in speakers for topics of interest and/or need. For example, having worked in various large Medical Centers where we had Residents and Fellows who would follow-up on erroneous orders by Physicians, I find myself now confronted at my current Hospital (mid-size Community Hospital; about 400 beds) having to try and stop my staff from just handing out anything that is ordered (i.e. MD orders 10 platelets; MD is really thinking of 10 platelets from whole blood donors but of course we don't use those anymore; RN would not listen to staff telling them they could not have 10 Apheresis products; I get call in middle of night and have to intervene with RN and educate: but other instances where MD orders > 2 apheresis at one time or 8 FFP in next 12 hours before patient goes to OR; things like that; and my staff just hands it out; am trying to get them to ask more questions and get me and/or Medical Director involved). But in a culture where they are used to giving what the MD ordered, and perhaps not knowing what is an improper order, I am bringing in a Medical Director from one of the large Facilities I used to work at to review transfusion of Plasma products. Also, L06, not sure if you are referencing the webiste above submitted by LisaM (but has my name at beginning so perhaps you think it was from me)??Brenda Hutson, CLS(ASCP)SBB Link to comment Share on other sites More sharing options...
Brenda K Hutson Posted June 8, 2010 Author Share Posted June 8, 2010 I've used a 'scavenger hunt' before on med tech students and techs alike. They find the answers to my questions in the SOP and they must give the answer and the location of the answer. That way I know they are actually looking in the procedure manual!I do like the idea of a crossword puzzle though. May have to try that sometime, if you don't mind.I like the idea of a scavenger hunt; will have to think on that one (to bring in SOP issues). I guess it is like everything else in life; people like to be entertained! So why not make it fun and productive at the same time?!Thanks,Brenda Link to comment Share on other sites More sharing options...
jcdayaz Posted June 8, 2010 Share Posted June 8, 2010 jcdayaz -Unfortunately, many on this site have stated that their institutions are not giving raises, some haven't for the last several years. (Yet, it doesn't seem right to complain about it when you look around at all the people who have lost their jobs, does it?)YOU ARE SO RIGHT!! We are fortunate to have a job! Each and every one of us that is still employed should be thankful. No one got raises last year. This year it is being called "possible". I am guessing we won't this year either. The possibility of a raise to complete compentencies, etc. keeps everyone doing them. Money talks, even if it doesn't materialize. Link to comment Share on other sites More sharing options...
jcdayaz Posted June 8, 2010 Share Posted June 8, 2010 [quote=Dr. Pepper;27I also ask my core BBer and the top 2nd and 3rd shifters if they have any issues they would like addressed. As a manager you can't see everything that happens, and if you're not routinely on the bench you don't have the point of view of a front-liner. Your last statement is HIGHLY intelligent and well said. It is unfortunate that some managers lose sight of the "front-line" work. I applaud you for not doing so. Link to comment Share on other sites More sharing options...
LisaM Posted June 8, 2010 Share Posted June 8, 2010 Brilliant idea! You go first, then you won't have to answer for a while!:D:D:D:DVoila! :http://www.bloodbanktalk.com/forum/showthread.php?p=27675#post27675 Link to comment Share on other sites More sharing options...
L106 Posted June 8, 2010 Share Posted June 8, 2010 I find myself now confronted at my current Hospital (mid-size Community Hospital; about 400 beds) having to try and stop my staff from just handing out anything that is ordered (i.e. MD orders 10 platelets; MD is really thinking of 10 platelets from whole blood donors but of course we don't use those anymore; RN would not listen to staff telling them they could not have 10 Apheresis products; I get call in middle of night and have to intervene with RN and educate: but other instances where MD orders > 2 apheresis at one time or 8 FFP in next 12 hours before patient goes to OR; things like that; and my staff just hands it out; am trying to get them to ask more questions and get me and/or Medical Director involved). But in a culture where they are used to giving what the MD ordered, and perhaps not knowing what is an improper order, I am bringing in a Medical Director from one of the large Facilities I used to work at to review transfusion of Plasma products. Also, L06, not sure if you are referencing the webiste above submitted by LisaM (but has my name at beginning so perhaps you think it was from me)??Brenda Hutson, CLS(ASCP)SBBBrenda -Yep, I meant to thank Lisa for telling us all about that education website. (Sorry, Brenda!)Regarding staff giving out "whatever the doc ordered": I think how each of the staff handles the scenarios you described depends on their technical knowledge, experience, practicality, and ability to question when something doesn't sound right. Great idea on the speakers to help in the knowledge area. Nobody like getting calls at home, but that's good if they are comfortable calling you, then they get to hear your thought process and see how you handle the situation. They will get better with more "Brenda" experience... Well, at least most of them.Donna Link to comment Share on other sites More sharing options...
Brenda K Hutson Posted June 8, 2010 Author Share Posted June 8, 2010 I agree that CAP would like you to sign off on new and revised P&P but does not require annual review and signing. (Our signoff sheets parrot back the CAP item # TRM.31190I verbiage). Brenda, you are right that annual review is not a bad thing if, as you say, they actually do it. That's the hard part, and it's a lot of info, often tedious, to go over.I have one wonderful core blood banker who knows it all, and 15 other generalists of varying degrees of wonder and BB experience. What I find useful for annual competency review is to include, among other things,the following:1. Pet peeves of mine (such as "writing over" incorrect log entries instead of drawing a line through it and dating and initialing. After the competency no one can say, "I didn't know...")2. Issues not generally encountered on a daily basis (such as P&P on maintaining blood services if the lab has to be evacuated, disaster plans, etc.).3. Issues and "what if" scenarios where you suspect everyone might not be on the same page.3. Opportunities for education, such as interpreting both a standard panel and an enzyme panel to remind techs which antigens are enzyme-labile, or having questions like "How many units should you have to screen to find 4 that are negative for E, K, Fya and S, and in what order would you use the antisera?" Educational info from the Principle sections of the P&P can be included as well.4. "Scavanger hunts" through the procedure manuals. If they can't find what they need to find, then I haven't done a good enough job making it easy to do so. It's also a great way to find and correct ambiguous, misleading or outdated material in the manuals.5. A few joke questions and silly pictures (the internet is a very rich source of zany pictures).I also ask my core BBer and the top 2nd and 3rd shifters if they have any issues they would like addressed. As a manager you can't see everything that happens, and if you're not routinely on the bench you don't have the point of view of a front-liner.Award a few modest raffle items (vendor pens and other swag, hospital coffee mugs, Doncan Donut cards, etc.).Along with the written exercise, we also do direct observation and occassional wet exercises. We are licensed in our state and require continuing ed; I award an hour CEU for the competency (the carrot on the end of the stick).You and I share that Pet Peeve (though I address it by giving the document back to the person who did it incorrectly and asking them to correct it; enough times of that and they "get the message"). It isn't that they have not been told numerous times in the past few years about cGMP; it is that they were not told "prior" to the past 3 years and there are a lot of old habits that die hard.I like your suggestions for training/ teaching/ reminding/ etc.For those of you who have others within your dept. that help write SOPs (you lucky people....); here is an exercise that I learned at an ASCP Workshop that I thought was fun (and I did teach it to the staff where I was working at that time as an Education Coordinator in that various staff members were given opportunities to assist in writing SOPs if they showed interest and ability).You purchase different colors of playdo (spelling??). You have staff sitting around a table (i.e conference room for educational activity if you are permitted such meetings). You tell everyone to take the playdo and make anything they want; give them about 10 mins. or so. Then you give everyone a blank piece of paper and ask them to write an SOP on how to make their object. When everyone is finished, you tell everyone to put their "clay object" under their chairs. You then tell them to pass their SOP to the person on their right (or left; doesn't matter). Each person is then instructed to "follow the SOP" and make what it says. It is very interesting (and funny) to see how far off some people are! But it also shows them how critical all of the aspects of SOPs are (i.e. materials; sizes; colors in this situation; etc.; you get the picture).Brenda Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted June 8, 2010 Share Posted June 8, 2010 I'd go along with that Brenda.The hardest SOP I ever had to write (for an exercise) was how to take a match from a match box and stike it, but only using one hand (to take out the match and strike it - not to write!), taking into account the Risk Accessment involved.:eek::eek: Link to comment Share on other sites More sharing options...
DPruden Posted June 8, 2010 Share Posted June 8, 2010 I don't know if our process is "fun" but we assign teams for annual SOP review. We include a management representative, someone who trains the SOP, our technical specialist, and a couple of bench techs and then the team goes through a chunk of SOPs and evaluates for regulatory changes, current practice, etc. and then the team decides if the SOP needs to be revised or not. We handle annual competency from CLIA/Joint Commission viewpoint and include 1. Direct observation of test performance, 2. Direct observation of instrument maintenance, 3. Monitoring of recording and reporting of test results, including a review of intermediate test results, worksheets, or QC, 4. Assessment of problem-solving skills, and 5. Test performance assessment using a blind sample. We hand out the forms at the beginning of the year and allow the techs to use their daily work to meet the requirements. Link to comment Share on other sites More sharing options...
Brenda K Hutson Posted June 8, 2010 Author Share Posted June 8, 2010 I don't know if our process is "fun" but we assign teams for annual SOP review. We include a management representative, someone who trains the SOP, our technical specialist, and a couple of bench techs and then the team goes through a chunk of SOPs and evaluates for regulatory changes, current practice, etc. and then the team decides if the SOP needs to be revised or not. We handle annual competency from CLIA/Joint Commission viewpoint and include 1. Direct observation of test performance, 2. Direct observation of instrument maintenance, 3. Monitoring of recording and reporting of test results, including a review of intermediate test results, worksheets, or QC, 4. Assessment of problem-solving skills, and 5. Test performance assessment using a blind sample. We hand out the forms at the beginning of the year and allow the techs to use their daily work to meet the requirements.Some of that sounds like the FDA requirements I am trying to find (when I get time). I recall not only the reference to Direct Observation for Testing, but also for Instrument Maintenance. In fact, I worked one place where we were cited by the FDA because the Techs. did the Tach and Timer on the centrifuges (had been started many years before I came; probably even before checklists were required) but there was no "documentation" that the staff was ever trained by the Hospital Engineering Dept. to use a tachometer, or that Direct Observations took place. Brenda Link to comment Share on other sites More sharing options...
DPruden Posted June 8, 2010 Share Posted June 8, 2010 Some of that sounds like the FDA requirements I am trying to find (when I get time). I recall not only the reference to Direct Observation for Testing, but also for Instrument Maintenance. In fact, I worked one place where we were cited by the FDA because the Techs. did the Tach and Timer on the centrifuges (had been started many years before I came; probably even before checklists were required) but there was no "documentation" that the staff was ever trained by the Hospital Engineering Dept. to use a tachometer, or that Direct Observations took place. BrendaI could send you our policy and form if that would be helpful. Link to comment Share on other sites More sharing options...
L106 Posted June 9, 2010 Share Posted June 9, 2010 We do the 5 things that DPreden outlined 3 or 4 posts ago. I remember that back when I wrote our original competency procedure I took most of my wording from what was spelled out in the CLIA requirements. Link to comment Share on other sites More sharing options...
conwaysbb Posted June 9, 2010 Share Posted June 9, 2010 (edited) I remember a long time ago I had to develop a Competency Assessment Program following cGMP requirements. I referenced a FDA article, so I went looking for it on the FDA website and found it. On page 7 of the GUIDELINE FORQUALITY ASSURANCE IN BLOOD ESTABLISHMENTS it states:Competency EvaluationTo ensure that all staff are trained and maintain theircompetency to perform all assigned tasks, the QC/QA Unitshould implement a formal regular competency evaluationprogram. A competency evaluation program should evaluatetheoretical and practical knowledge of procedures including,but not limited to, the following:(1) Direct observations of performance of routine and qualitycontrol procedures including, as applicable, donorsuitability, sample handling, processing, testing,labeling, and instrument preventive maintenance;(2) Monitoring the recording and reporting of test results byreviewing work sheets, quality control records,preventive maintenance records, and other records andentries (both manual and automated);(3) Written tests to assess problem solving skills, knowledgeof SOPs, and theory; and(4) Assessment of performance using internal blind specimensand external proficiency test specimens.Minimum acceptable scores, performance, and remedial measuresto correct inadequate performance on competency evaluationsshould be documented and retained in personnel records.Evaluation summaries provide useful information to correctindividual or group performance problems.The specific website is:http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM164981.pdf.Although this is from 1995, it is still appropriate today and I have never had anyone question my competency assessment program.I and my senior level staff who perform training and competency assessments, do not directly observe every single task. Howwever, as we review all QC records, PM records, transfusion reaction workups, antibody workups, Computer exception reports, Testing worksheets/logs, etc. we use these as part of the competency assessment. I also give every member of the staff a 20 question, open book quiz. As the whole purpose of SOP manuals is for staff to review and read if they can't remember every step in a procedure, then letting them look up the answer in the SOP manuals is appropriate too. We do give all testing personnel Tech Chek samples from Immucor or a CAP specimen. Of course I have minimum acceptable scores for the written quizes and the Tech Cheks/CAP samples.We have done crossword puzzles, but instead of having to do the crossword diagrams myself, there are some free crossword internet sites that will actually just allow you to enter a list of words and it will create the crossword for you. Much easier to do, then trying to do it yourself. :-) Edited June 9, 2010 by conwaysbb Link to comment Share on other sites More sharing options...
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