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Cliff

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Blog Entries posted by Cliff

  1. Cliff

    Test
    General Thoughts
    First, following these tips will not ensure citations are not issued.  This guide is designed to help you survive your first, or hundredth, inspection.  Feel free to leave your tips in the comments below.
    I have led or been part of a team that has hosted dozens of inspections over more than two decades.  Below are some tips on how to prepare for your first inspection, respond to your inspector, and survive with your sanity intact.
    I may be glib at times in this post, but I do take this process very seriously.  You may lose a prestigious accreditation, or worse, the ability to perform a critical test.  Occasionally substantial fines can be involved.  Rarely, prison sentences are imposed.
    Keep good notes. document everything and keep copies of everything – more below.
    Notifications
    Keep people apprised.  I suggest creating a group email address now, not on the day of the inspection, but now.  It should include your leaders, leaders of other areas that may be impacted – Nursing, Admissions…, your direct reports (unless that is line staff), and others that may need to know.  I promise you will forget someone, that’s OK, add them to the list and move on.  On the arrival of the inspectors, send a quick note to that list letting them know basic details: agency, areas they are likely to review, expected length of inspection, time / location of the opening meeting (if there is one).
    Create an email to send to staff, do this now, again not on the day of the inspection.  Save it somewhere as a Word document so you can quickly copy and paste the information into an email.  It should include items such as, only answer what you are asked, ensure you have your institution provided ID worn as required, say “I don’t know, I would ask my manager…”.
    At the end of each day, send out a summary to the leaders list.  If there are findings, let the leaders know.  Also notify line staff.  This is an inspection of their work; they need to feel proud of what they have done.  You may want to hold back on any citations (if any) until you have developed a fix.
    Types of Inspections
    The terms below are a few of the more frequent organizations you may encounter during an inspection.  There are several terms used for the process, for the purpose of this post, I will use “inspection” to represent the different terms, and “agency” to capture all inspection organizations.  For anything that goes awry and is documented as needing improvement, we’ll use “citation”.
    FDA       Inspection AABB    Assessment TJC        Survey CAP       Inspection FACT     Inspection ISO        Conformity assessment GCP       Inspection Announcement
    Inspections are designed to be a surprise.  Some agencies will give you a window of when they are likely to arrive, others do not provide any information at all.  This is by design.  It is the expectation of the agency that you are always ready for an inspection.
    Continuous Readiness
    You are always ready to perform testing on a patient specimen, correct?  The same should be true for an inspection.  You need solid processes in place for all the items an inspector will look for.  These are important for inspections, but more important for patient testing.
    A short list of activities you need to have procedures for, and most important, documentation, follow:
    Correlation studies Transfusion Reaction Investigations Competency Assessment Training (this is not competency) Equipment maintenance records – as required by the manufacturer Quality control (signed by an approved person) Personnel records – evidence of an annual review, qualification for their position How to write an SOP Organizational structure - this does not need to be a beautiful chart, it can be as simple as a listing of what position reports to whom, and their general duties Speak When Spoken To
    Think of an inspection as a first date.  You will be nervous, regardless of this being your first inspection or 20th.  There will be many times of extended quiet – sometimes an hour or more.  Bring your laptop, cellphone, or something else private for you to work on in the presence of the inspector.
    During these quiet times, you may get extra nervous.  The inspector may take notes, may mumble to themselves while reviewing an SOP, may furrow their brow when looking over quality control records… do not be tempted to ask if they need anything.  Trust me, they will ask.
    Do not be belligerent but be close.  When asked a question, answer the question honestly and fully, but only to the point of answering the question.  For example, you’re asked “Do you perform quality control on reagent xyz?”.  Answer according to your SOP, then stop talking.  Do not respond with “Yes, we perform daily quality control on reagent xyz; however, we feel we could improve how we document this information and have begun a process improvement project to address this.”.  This will lead to more questions, and a possible citation.
    Sadly, we’ve all had the inspector who will respond, “No worries, it’s not an actual rule, but it’s they I’ve always done it.”.  Do your best to smile (at least inside) and do not respond.
    Be Honest
    You know where your weaknesses are.  Please do not point them out (see the section above).  If an inspector fails to uncover a process you plan to improve, no harm is done.
    If an inspector asks about a process you are not performing correctly, answer the question directly.  For example (US based) “I was reviewing employee 123’s training record.  I see you’ve done a terrific job training them on Process ABC.  I really like your training documents, great work.  I also see they have documented independent performance of test ABC one week after they were trained.  Please show me the documentation of their competency assessment.”.  You do not have this documentation.  Uh oh.  You’ve been caught, own up to it.  A possible response: “Thank you for recognizing the hard work we put into training our staff, we really are proud of it.  As you noticed, employee 123 does not have documented initial competency, this is something we are working on.  Can I show you our project plan for bringing this into compliance?”.   This is a serious concern for inspectors, and you may be cited, you may not, based on your project plan.  The crucial point is to not argue with them.
    Do Not Argue
    Should an inspector find something they don’t find quite right, ask for clarification.  Something that I found helpful is, “Thank you for pointing that deficiency out.  We take our work very seriously.  As you can imagine, process change is a critical step in our continuous quality improvement and needs to be agreed upon by senior management.  Can you please let me know what regulation I am not fulfilling – specifically with the rule number.”.
    If you are going to be cited, you are going to be cited.  Do not get defensive, do not argue, do not try to negotiate.  There is time to do that in your response.
    Ask for Specifics
    Let’s say the inspector say, “Please show me quality Control.”.  That’s a big request.  Ask for clarification. 
    You:                    “I would be happy to provide you quality control information, can you please be more specific?”.
    Inspector:          “Yes, I want to see reagent quality control.”.
    You:                    “Can you please provide a date range for the records you would like to see.”.
    Inspector:          “Please give me last month, and the same month for the prior year.”.
    You:                    “Is there a particular reagent or process you would like to see?”.
    You get the point.  You are not trying to be uncooperative or unhelpful.  You only want to provide exactly what they need.  More is not better.  Do not attempt to bury them in data, they will find every unchecked box and unreviewed document you have.
    Document What They See
    Always provide an escort for your inspector(s).  Never let them walk through the laboratory on their own, even to go to the restroom.  Clearly do not follow them in; however, observe them as they head out of the laboratory toward the restroom, then stay within sight of where they will return.  They will be observing what is going on as they walk through, and if something piques their interest, they may stop and ask questions.  You need to be present for this, so you have a firsthand account of what transpired.
    Many times, an inspector will ask for documents to be provided as a copy.  Depending on the agency, you may not be allowed to redact.  One example in the US is the FDA.  Unless you are given permission to redact, you must provide anything they ask for, including private / protected information. 
    Always make a copy for the inspector and an identical copy for yourself.  Keep these documents in your folder for that inspection and maintain them.
    Do a Gap Analysis
    Performing a gap analysis is an amazing opportunity.  Pick the most critical set of rules you’re required to follow.  It’s wonderful when these rules are available for download.  Don’t make the process overly complicated.  Add the rule to a column in a spreadsheet.  In the next column document the exact location in the SOP where you are fulfilling this rule.  Some document management systems allow for the recording of this, but if you do not have this available to you, again, a simple spreadsheet will suffice.
    I assure you, you’ll learn a lot doing this exercise, most importantly, that there will be items you assumed were in your procedures that are not.
    This is a fun process, but it takes resources.  If you are doing this on your own it could take months, maybe an entire year.  Ask your staff for help.  Give them clear instructions on what you need them to do, give them small chunks at a time to work on.  I promise they will enjoy the education and chance to help improve your overall quality.
    There is zero chance you will complete this task with no processes to improve.  This is OK.  Now you know where your weaknesses are and can prioritize working on them.
    Response to Inspection
    Most agencies tell you how they want you to respond, and when.  Examples: AABB has a format they prefer you to follow when responding – use their document.  TJC has timelines for when items must be corrected, and more timelines for evidence of these corrections - meet these timelines.  FDA (unless it’s a Warning Letter) does not expect a response.
    The key point, the inspecting agency has a proposed format, use it.  Never be late with your response.  If circumstances do not allow you to meet the deadline, well in advance of when your response is due, ask for an extension.  The agency will often grant one.
    If the agency does not require a response, respond anyhow.  For instance, if the FDA finds one item that needs attention, write to them thanking them for their time, let them know you appreciate the thoroughness of their investigation, and describe specifically how you have corrected the deficiency.  They will likely mention this the next time they visit, and it will set a positive tone for that inspection.
    If you are fortunate enough to survive the inspection without a citation, still write a letter thanking the agency for their time.
    Closing Notes
    This may be your first inspection, but it will not be your last.  It is part of doing business in a laboratory.  Accept that fact.  Develop a procedure for inspections: do you provide parking; do you offer lunch…  Learn from missteps you had during each inspection. 
    Most important, don’t take a citation personally.  Learn from what your inspector provided you and get better.
     
  2. Cliff
    We’re excited to have PathLabTalk turned back on.  We think you’ll like the many new features of posting on the site.
    Before you can use the site you must follow these steps.  You will not be able to post unless you do.
    If you are still logged into the site, you must log out. Clear ALL of your cookies related to the site and ALL of your browser cache. Close your browser. Reopen your browser and log in. You must do this for each device you use for the site, including mobile devices. The site may look a little different, but most of the features we previously had should still be there, plus there are many added features.
    Most links you had prior to the upgrade will no longer work, please reset your favorites.
    The new editor automatically adds a paragraph return when you press enter, so no more need to press enter twice when starting a new paragraph.
    Some forums have been eliminated to streamline the look of the site.  In particular, the Hot Topics forums have been eliminated.  All of the topics have been preserved, just moved to their correct forum.
    We’re excited to announce a new option, Premium Membership.  This site has remained completely free for your use for over 10 years and will always remain this way.  There is now an option to help support PathLabTalk and use a few more features the site has to offer.  You can learn more by clicking the Store tab at the top of any page.
    There may still be a few items that are a little “buggy”, we are working hard to fix those items.  This was a significant upgrade, and these types of upgrades often come with a few items that need cleaning up.
    If you have any issues or need help using the site, please use the live help link on the left of any page – and please be patient waiting for your response, this is a big upgraded, and while we expect it to work well, there are always hiccups.
     
  3. Cliff
    The PathLabTalk site has been moved to a new server.
    This new server should at least as fast as the old one.
    We moved because we were getting occasional errors with the old server, and we want to provide as stable as an environment as possible.
    Please report all bugs here.
    Thank you
  4. Cliff
    PathLabTalk uses a newsletter program to send our daily newsletter. To sign up for our daily newsletter you can select from one or more of our 20 newsletters available here.
    We have over 1,000 people subscribed to the newsletters; however, we occasionally receive reports that the newsletter is not being received.
    If you have confirmed the newsletter is not going to your spam folder, and you have contacted your place or work (assuming you have it delivered to your work email) to ask them to not block mail from pathlabtalk.com and pathlabtalk.net, then please post a short message here letting us know.
    We know this is frustrating and we are trying to resolve this issue.
  5. Cliff
    Due to many issues, mostly with being unhappy with the current software vendor, PathLabTalk will be moving to new software.
    Yes, there will be differences and yes it will take a little getting used to.
    What won't change is your username or your password, that will remain the same.
    There will be intermittent downtime while we import to the new software this weekend (April 20, 2013 - April 21, 2013).
    We appreciate your patience and assure you we will do our best to make this as smooth as possible.
    When the new software comes live initially only the forum posts and blogs will be active, however, there will be other tabs for future enhancements that will come online at a later date. We will work to get the Library moved over also, that may prove to be a little trickier.
    As always your comments and suggestions are welcome.
  6. Cliff
    There are some sections of this site that get used less than others. Some require different pieces of software to run them adding to the complexity of running the site, and making it feel more cumbersome to navigate than it really is.
    I would like to propose that some of these sections be removed, but the choice is yours.
    Please reply to this blog posting with your thoughts either way.
    The sections I am considering removing are:
    Classifieds
    Bloopers
    Links
    Thank you for your input.
  7. Cliff
    There is a new page on the site, Charities.
    I have started to participate in challenge bike rides to help raise money for various charitable causes. I started in 2012 with a couple of small rides and plan to add longer rides in future years.
    If you are interested in donating to my rides, please view the rides I am participating in here.
    Thank you for your support,
    Cliff
  8. Cliff
    I got this message from a member, and they gave their permission to share.
    --------------------------------------------------------------------------------------------------------

    Dear Cliff,
    First of all sorry that I haven't react in any way your welcome message, but 4 years ago when I joined the Hungarian Blood Bank and a bit later the Blood Bank Talk community (beeing a logistic expert) I was sure I would never be able to contribute your conversations. You know I had a foggiest idea what blood banking ment at all, and to tell you the truth even now I only guess what the majority of the topics are about.
    Anyway I thought reading the threads was an excellent chance to practice my English. So I became your diligent reader. Slowly I got acquainted with Malcolm, Deny Morlino, David Saikin, Auntie-D, Mable Adams, and the others and enjoyed so much their communication except for those horrible abbreviations...
    I must say I am really envy of your profession and the helpfulness and devotion what is so tipical of every single one of you.
    The event that is accountable for my turning to you is that soon I am leaving the Hungarian BB and continue my career in a business that has nothing to do with blood. I looked for the suitable point on the home-page to unsubscribe the e-mail list, but I failed. As fare as I noticed you are a sort of a system administrator here, so I hope you can solve my problem.
    I wish all the best to your blood bank community and farewell,
    Eva Jaszay
    Budapest
    PS: If you think so, share my letter with the others, and please forgive me my grammatic mistakes.
    --------------------------------------------------------------------------------------------------------
    Eva,
    Thank you very much for your kind words, and this is an international forum, don't worry about your grammar enhancements.
    Cliff
  9. Cliff
    You may have noticed hidden in the Help / Info menu PathLabTalk has an Arcade installed. Actually almost since the site has started there was an arcade.
    The previous arcade (previous to today) had a significant security issue and needed to be removed. No fear, your Asteroids score was not shared with the world. :cool:
    The sad news is your scores were deleted. The good news is we have all new games for you to try and beat.
    As always, please post any site errors here.
  10. Cliff
    The main forum software, as well as many of the supported / related software tools, has been updated.
    The most noticeable update will be the post / reply editor. PathLabTalk is now using one of the most popular editors used for sites. This will give users a more familiar feeling while posting. Another great feature is we have turned the auto-save feature on for the editor. Every 30 seconds what has typed will be saved. That way if you close your browser by accident, or simply leave the page before you click submit, everything you typed will still be here for you when you return - that's pretty cool for us two finger typists.
  11. Cliff
    We have had a Thank You button on the site for many years. The one we were using was acting very erratically and was recently disabled.
    A new button developed by a different programmer has been implemented, and the best part is we were able to import all of the prior Thanks data.
    Please let us know if you have any problems with the new button, or if you like it.
    "Thanks"
  12. Cliff
    We have some sad news about how PathLabTalk communicates with you.
    We have had a voluntary Newsletter for many years, yet we have now been marked as a spammer by those same Newsletter recipients.
    It's a shame that so few have so much power, but that's the wonderful world of the internet.
    Effective May 20, 2011, we will no longer send Newsletters to current subscribers.
    We now have a spam compliant process for signing up for our Newsletters.
    Please click here to sign up.
    This is the last email you will receive from this Newsletter list.
    In order to continue to receive Newsletters, you must click here and re-subscribe.
    We apologize for the inconvenience.
  13. Cliff
    We've installed a mobile style for the site.
    Obviously this is only intended for those that want to use a mobile device to view the site. This mobile style is optimized for all webkit mobile devices in most languages, and will auto-detect if a user visits the site from a mobile device and render the site in the mobile style.
    Please let us know what your experience was if you try it out.
    Also, we are considering a dedicated style for the iPhone and Android phone. Again, please let us know of your interest in this option. We won't purchase the license if the usage will be low.
    Thanks for your feedback!
  14. Cliff
    With the planned growth of PathLabTalk, we need an easy way to navigate the many new sections.
    The plan is to have a slightly different color scheme for each of the different forum sections. This will help you keep track of where you are.
    Each of the menus will have a slightly different color scheme too and the logo will swap depending on the section you are in.
    We will add a Library section for ChemLabTalk, HemeLabTalk and MicroLabTalk.
    The menu will be huge, but we want to make it easy to navigate at the same time.
    I have posted a temporary menu, it is a very early beta set-up and this will not be the final menu.
    I wanted to give everyone a chance to have their input.
    It will be changing on a regular basis, so don't be upset if it's not what you hoped for, we'll get it there.
    Here is the temporary home for the menu:
    http://www.pathlabtalk.com/site_menu/test/html-drop-down-mega-menu.html
  15. Cliff
    If you're reading this, then you are either a new member, or you are a loyal member who found our new location.
    The BloodBankTalk site was moved to the new address yesterday.
    The new permanent home is here at PathLabTalk.com.
    As we previously mentioned, over the coming few weeks we'll be adding the new sections, ChemLabTalk, HemeLabTalk and MicroLabTalk. One of the challenges we are facing is developing an easy menu system that will allow members to navigate a much larger site without ever feeling lost. We have a plan in place and you'll see changes incrementally.
    We know there are a few minor glitches now, and we are working on them. Your help in identifying issues would be greatly appreciated. Please post any errors you see in our support system. http://pathlabtalk.net/support/
    Best regards, and Happy New Year,
    Cliff
  16. Cliff
    BloodBankTalk has enjoyed great success over the past 5+ years, all thanks to you.
    We've decided to expand. We'll keep all the same great content we have now, and we'll add options for all of the other pathology labs that show an interest.
    Please visit this post to vote for the new name / web address.
    Updates 8/30/2010
    I understand some people are concerned about what this means for BloodBankTalk.
    While all of the details have not been worked out, here is how we see the site moving forward.
    The URL (link) to get to BloodBankTalk will change. The post listed above will decide the new URL - you choose. After the change is made and you type in www.bloodbanktalk.com it will automatically forward you to the new site. We will always keep that name registered. The easier way to get to the site will be to type in the new address - or click a link in the newsletter.
    There will be a similar menu system to what we have now, there will likely be different tabs for each of the different forums. All of the content from one forum will remain in just that forum. If you click the bloodbank tab it will essentially look like it does now.
    Each new section will be color coded. As an example all pages related to chemistry will have a red theme, all pages related to heme will have an orange theme, all pages related to blood bank will have a blue theme. The last part will remain true - the bloodbank section will keep the same color it has now to maintain familiarity.
    The logo on the top left of the site will reflect what section you are in. If you are in a bloodbank section, it will display the same logo you see now, if you are in micro you will see a micro logo.
    The ads will be relevant to each section. When you are in a chemistry page the ads will be chemistry related ads, when you are in a bloodbank section, you will see the same ads you see now. Te ads will not cross over to other sections - this way they will be relevant to the section you are viewing.
    The newsletters will be specific to the sections you want to receive. If you choose to get heme and bloodbank, you'll get only those newsletters - you choose.
    One of the biggest benefits to the members of the site will be the addition of many new members. You'll have the option to visit and contribute in the other sections if you choose, or you can remain only in the bloodbank section - the choice is yours.
    As always, your comments and suggestions are welcome. I hope this clears this up a little and I didn't make it more confusing.
  17. Cliff
    This site (as well as most modern sites) is best viewed with a modern browser.
    We highly recommend using IE 8 or FireFox 3.6+.
    There are known compatibility issues when using IE 6 or lower, these issues will not be resolved as IE 6 is a very old browser and will be sunset by Microsoft soon.
    Currently there are minor compatibility issues with IE 7, but they seem to be resolved with IE 8 or FireFox 3.6+. We are working to resolve these issues.
    Feel free to post comments or suggestions.
  18. Cliff
    We've upgraded to the newest version of the forum software.
    Updating the forum was quite simple, updating the rest of the site is going to take a few more days.
    Most of the functionality previously available is currently working.
    One pending key item is the document library.
    This should be available in the next few days. We'll update this post to keep you apprised of what is still pending.
    Pending Items (as of August 4, 2009)
    Bloopers - fixed 8/4/10
    Product Reviews
    Document Library - Fixed 8/4/10
    Announcements - fixed 7/26/10
    Advertiser List - fixed 7/26/10
    Data Calculators
  19. Cliff
    The Announcements section of the site has been updated to the new (future) look of BloodBankTalk.
    The top section where the menus are is essentially the same, but the display and the new Announcement submission form have been updated.
    Take a look and let us know what you think.
  20. Cliff
    Significant upgrades will be coming to BloodBankTalk.
    Some changes will be cosmetic, others will be more significant.
    To make the transition easier for all of the sites users, the changes will be implemented slowly over the next two months.
    Today we will be switching the vendor we use for the classified ads. The current ads will be imported into the new system.
    Stay tuned to this section for more updates.
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