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sgoertzen

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Everything posted by sgoertzen

  1. To be an assessor for AABB, you have to currently work at an AABB accredited facility and be an individual AABB member as well. If you meet these requirements and you meet the experience requirements, you can apply to be an assessor. It is a big commitment, but well worth it! They expect you to make a real effort to attend the assessor day training each year at the AABB annual meeting and to accept and complete a minimum of 2 assessment assignments each year. If you have to miss the annual meeting for whatever reason, they do allow you to make it up with on-line training, but it's required that you get your initial 2 day "new assessor" training and preferred that you get your subsequent annual assessor training at the face-to-face annual meeting each year.
  2. AABB does not require or recommend that you give group O washed blood to neonates < 4 months of age. I work at an AABB accredited children's hospital (so lots of neonate transfusions) and we have never used washed blood for them during the 28 years I've worked here. 31st Edition of AABB Standards for Blood Banks and Transfusion Services: 5.17.2 If a non-group-O neonate is to receive non-group-O Red Blood Cells that are not compatible with the maternal ABO group, the neonate's serum or plasma shall be tested for Anti-A or Anti-B. 5.17.2.1 Test methods shall include an antiglobulin phase using either donor or reagent A1 or B red cells. Std. 5.14.3.4 applies. 5.17.2.2 If anti-A or anti-B is detected, Red Blood Cells lacking the corresponding ABO antigen shall be transfused. Our policy is that we routinely give neonates fresh group O Leuko-reduced, Irradiated, CPDA RBCs, but if they must be given something other than group O (example: a directed donor unit), then we require a full AHG crossmatch be done on the unit using baby plasma.
  3. We're in the midst of moving to Epic. We'll have Beaker for the Lab and WellSky (formerly Mediware HCLL) for the Blood Bank. Still too early to tell if we'll be happy with HCLL since we're still building it and will Go-Live in April 2020.
  4. We're a children's hospital in the process of building Epic/Beaker/WellSky (Mediware HCLL) with Go-Live set for April 2020. We've bumped into a huge problem with Epic stating that our outpatient drawing area must use their Epic/Beaker outpatient product which does not allow for electronic (scanned) patient/sample ID and there will also be no patient ID bands. We've been using electronic ID of patients and samples with our current system (MediTech), so losing this functionality would be taking a major step backwards for us - especially with our Pre-Op patients and their blood bank specimens. We don't want to have to go back to requiring 2 specimens collected at different times on all first time blood bank patients, and using no ID bands just sends up giant red flags to me as far as patient safety is concerned. Is anyone else experiencing "no ID bands and no scanning verification of ID band vs. specimen label" in their outpatient areas? How are you dealing with this? I'm hoping that I can get some advice from all of you Epic/Beaker users. Thank you so much!
  5. We're a children's hospital in the process of building Epic/Beaker/WellSky (Mediware HCLL) with Go-Live set for April 2020. We've bumped into a huge problem with Epic stating that our outpatient drawing area must use their Epic/Beaker outpatient product which does not allow for electronic (scanned) patient ID and there will also be no patient ID bands. We've been using electronic ID of patients and samples with our current system (MediTech), so losing this functionality would be taking a major step backwards for us - especially with our Pre-Op patients and their blood bank specimens. We don't want to have to go back to requiring 2 specimens collected at different times on all first time blood bank patients, and using no ID bands just sends up giant red flags to me as far as patient safety is concerned. Is anyone else experiencing "no ID bands and no barcode scanning of ID band vs. specimen label" in their outpatient areas? How are you dealing with this? This problem isn't related to SoftBank vs. WellSky so I'm hoping that I can get some advice from all of you Epic/Beaker users. Thank you so much!
  6. Someone above commented that a 2nd sample is only required in the U.S. for computer crossmatch (which used to be true). But with the 31st Edition of AABB Standards (effective April 1, 2018), this requirement was moved so that it now applies for all pretransfusion testing for allogeneic transfusions including all types of crossmatching (IS, AHG, and Computer crossmatching). This is more in line with CAP requirements and makes more sense in order to detect possible Wrong Blood In Tube (WBIT) events. AABB Standards for Blood Banks and Transfusion Services, 31st Edition 5.14.5 Pretransfusion Testing for Allogeneic Transfusion There shall be two determinations of the recipient’s ABO group as specified in Standard 5.14.1. The first determination shall be performed on a current sample, and the second determination by one of the following methods: Testing a second current sample. Comparison with previous records. Retesting the same sample if patient identification was verified using an electronic identification system or another process validated to reduce the risk of misidentification. Standards 5.11 and 5.27.1 apply. Personal Note: If you intend to retest the same sample (by a different person or the same person), be prepared to show the AABB assessor your validation proving that your "another process" is actually validated to reduce the risk of misidentification (i.e. WBITs). CAP Checklist Requirements: TRM.30575 Misidentification Risk The facility has a system to reduce the risk of mistransfusion for non-emergent red cell transfusions. NOTE: Mistransfusion occurs from misidentification of the intended recipient at the time of collection of the pretransfusion testing sample, during laboratory testing and preparation of units to be issued, and at the time of transfusion. Misidentification at sample collection occurs approximately once in every 1,000 samples, and in one in every 12,000 transfusions the recipient receives a unit not intended for or not properly selected for him/her. The laboratory is expected to have implemented a plan to reduce these risks through implementation of a risk-reduction system. Among options that might be considered are: (1) Verifying the ABO group of the intended recipient on a second sample collected at a separate phlebotomy (including the recording of the result in the institution's historical record); (2) Utilizing a mechanical barrier system or an electronic identification verification system that ensures that the patient from whom the pretransfusion specimen was collected is the same patient who is about to be transfused. Other approaches capable of reducing the risk of mistransfusion may be used. The laboratory should participate in monitoring the effectiveness of the system that it implements. The laboratory should also consider improvements in procedures and/or educational efforts as part of its program to reduce the risk of mistransfusion. TRM.40670 ABO Group and Rh(D) Type Verification The recipient's ABO group and Rh(D) type has been verified by repeat testing of the same sample, a different sample, or agreement with a historical type in the laboratory's records. NOTE: Repeat testing of the same sample may be inadequate unless the sample has been drawn using a mechanical barrier system or digital bedside patient identification system. For laboratories that employ computer crossmatching, serologic crossmatch techniques must be employed when ABO typing discrepancies are present (e.g. mixed field reactivity, missing serum reactivity, apparent change in blood type post hematopoietic stem cell transplant).
  7. We designed and ordered special labels that we attach to our psoralen platelets. The ISBT codes for our products are E8331, E8332, E8333, E8334, E8335. Psoralen-Treated Platelets Place this label on all Psoralen-treated (Pathogen Reduced) INTERCEPT Platelets to remind the care provider that they are equivalent to IRRADIATED and to store at room temp.
  8. We've been using leukoreduced RBCs and PLTs in lieu of CMV seronegative for over 20 years for all pediatric (including neonate and micropremie) transfusions. I work at a 350 bed children's hospital with a large NICU, 3 satellite NICUs, an active ECMO and heart surgery program, and we care for many children who receive bone marrow or organ transplants. We converted to this back when studies showed that leukoreduced products were found to be basically equivalent to CMV seronegative products for rate of CMV transmission. We use leukoreduced for all transfusions (including exchange transfusions) regardless of patient age or size. We have never had a case of CMV transmission through transfusion. Over 80% of our blood donors are CMV positive in our area.
  9. I received this email below from jeskarmazinmd@gmail.com on 1/18/2019. You may want to contact Dr. Karmazin if you have any healthy plasma collected from young donors (16-25 yr old) that you would like to sell. Hi, I am interested in setting up an account to order young plasma (FFP), from donors ages 16-25. My company, Ambrosia, is focused on using young plasma as a restorative treatment for chronic illnesses. We have had success over the last several years, including a clinical trial completed in 2018. Please let me know if you have any questions. Thank you, Dr. Jesse Karmazin
  10. This is the way Meditech documents the splitting of products. Now with ISBT, the product code does not change when you split, so this is how the computer differentiates one split from another made from the same product. The split number (A, B, Ba, whatever) needs to print on the tag so you can tag the product properly and the blood bank and bedside staff know which split is being issued and transfused. I've had Meditech 27 years, we're a pediatric hospital so we make tons of aliquots, and no inspector (CAP, AABB, FDA, JC) has ever had a problem with this. Your CAP inspector should not cite you for something they don't understand. The previous post is correct - adding an A or B to the DIN when splitting has nothing to do with a closed or open system. I would challenge that citation.
  11. For many years we have been using borosilicate glass tubes (12 x 75mm and 10 x 75mm) with a patch for writing on them to perform our blood bank testing that needs to be done in tubes. We currently purchase ours from Kimble-Chase - item numbers are 60A10BZW and 60B12BZW. As companies have merged over the years I guess things have changed because one of our blood bankers recently noticed some very small print above the barcode on the box of tubes that says: "For Research use only. Not for use in diagnostic procedures." I would consider blood bank testing performed in tubes to be a "diagnostic procedure", so we've gone in search of an alternate vendor for glass tubes with a patch specifically made and approved for blood bank tube testing. We can't find anything out there on the market. We've checked with other local hospitals and they had never noticed this message until we brought it to their attention and are choosing to ignore the manufacturer's message and continue to use the tubes. What vendor is everyone else using?
  12. We've used TAR for years and it works well. We use the regular hospital ID band (where the barcode is the patient account number) - we do not use a special band. The nurses must scan the patient ID band and all 4 quadrants of the product label. We still require that 2 nurses Esign in TAR after completing their bedside checklist. We have built all their necessary non-scanable checks into this checklist (AAB Std 5.28.3). We use TAR everywhere except SURGERY, since they have their own system (called O.R. Manager) and they do not use Meditech in the surgery suites. We do not print a paper form for any location but SURGERY. For blood issue, we use a pick-up slip (we have them preprinted as pads that they keep at the nursing stations throughout the hospital) where they must fill out the patient name, MR#, Acct#, and what product they want to pick up.
  13. Beaker does not offer a blood bank module, so those hospitals going to Epic/Beaker must select some sort of standalone system for the blood bank. I'm interested to see comments because I will also be in this exact spot about 6 months from now (switching from Meditech 5.67) and I don't know which system to propose they purchase for just the blood bank department. Haemonetics SafeTrace, Mediware HCLL, Softbank, Sunquest????? I have no experience with any of them. Our whole hospital has been using Meditech since 1991. Those with experience integrating a blood bank system with Epic/Beaker... please offer your advice! We need a system that will accommodate bedside scanning/administration record, electronic crossmatch, as well as lots and lots of aliquoting and modifying since we are a children's hospital.
  14. Yes, we use this small 4C2223 tubing/filter set for transfusion of all blood products that they choose to pull into a syringe at the bedside.
  15. I've attached the form I came up with that we use. Here is the section in my procedure that addresses method correlation: CAP Checklist: COM.04250 If the laboratory uses more than one nonwaived instrument/method to test for a given analyte, the instruments/methods checked against each other at least twice a year for comparability of results. NOTE: This requirement applies to tests performed on the same or different instrument makes/models or by different methods. This comparison must include all nonwaived instruments/methods. The laboratory must establish a protocol for this check that includes acceptance criteria. Quality control data may be used for this comparison for tests performed on the same instrument platform, with control materials of the same manufacturer and lot number. Otherwise, the use of human samples (whole blood, serum, plasma, urine, etc.) rather than stabilized commercial controls, is preferred to avoid potential matrix effects. In cases when availability or pre-analytical stability of patient/client specimens is a limiting factor, alternative protocols based on QC or reference materials may be necessary but the materials used should be validated (when applicable) to have the same response as fresh human samples for the instruments/methods involved. Method Correlation is performed twice a year, comparing Echo1 vs. Echo2 vs. Manual Capture vs. Tube methods 1. ABO/Rh – No less than 3 specimens are compared, each with different blood types, at least one should be Rh negative 2. Antibody Screen – No less than 3 specimens are compared, at least one should be positive 3. Antigen Typing – comparing tube to Echo, no less than 3 specimens 4. Antibody ID – No less than 1 positive specimen is compared Interpretation/ Acceptance Criteria: · Manual and Automated Capture methods are expected to correlate closely. · Echo1 vs. Echo2 results are expected to correlate (match) closely. · Capture vs. Tube methods are expected to show some variability between reactions due to the differences in the nature of the testing systems and enhancements. · Corrective action must be taken and documented when criteria are not met. Hope this helps! Sheri Q0530F03 Method Correlation 8-12.doc
  16. Our entire hospital uses TAR...except Surgery. They refuse to use Meditech and use their own O.R. Manager system which does not interface with Meditech so their transfusions are still done on paper and are scanned into the EMR. So our big problems are with units started on the floor and transported with the patient to Surgery, and units started in Surgery and transported with the patient back out to the floor. We have to print paper transfusion forms for documenting either the beginning or end of those transfusions. We have never used separate BB bands but use the regular barcoded hospital band - both for inpatients and outpatients. We really like TAR. You can build the nursing checklists and vital screens with whatever fields you want completed. Unfortunately, Meditech has not built all screens/interventions/assessments with the capability of setting a requirement that the field MUST be completed prior to filing, so we occasionally still see some missed vitals, or missed checklist items (like a check for special requirements). Those "missing" items are now being tracked and reported as part of our ongoing quality monitors, and we've seen compliance get much better.
  17. Here is a copy of our Level 2 Annual Blood Bank Competency form. We also have a Level 1 (for just label checking and issuing blood), and a Level 3 for advanced Blood Bank competencies. Q0230F06 Level2BBKComp 11-11.doc
  18. AABB Std 5.25.5 requires "The records shall contain a signed statement from the requesting physician indicating that the clinical situation was sufficiently urgent to require release of blood before completion of compatibility testing or infectious disease testing". Notice that this requirement is not hinged on whether the patient actually gets transfused with the emergency released blood. The fact that blood was requested prior to completion of testing requires the physician's signed statement, regardless of whether they end up transfusing it or not. So yes, you need to keep the emergency release form with the physician signature. If the form is returned with no signature, you should also chase the doctor down and get that signature, even if the blood was not given. It can be a hassle, but those are the standards.
  19. We have validated the electronic crossmatch with Meditech CS 5.65 and I agree with bmarotto. We followed the Meditech validation plan, but then also created additional "stress" situations as mentioned above (age of specimen, aliquots, modified products, previous positive Ab screens, different types of antibodies, etc.). The computer is using rules and logic from several areas to determine whether the EXM should invoke or not, but this isn't RBC product code dependent. I don't feel it's necessary to validate every single product with every possible donor type, since Meditech is simply looking at whether the product requires a crossmatch or not, and if it does, all the EXM rules automatically trigger. You've already validated all of your blood type compatibility truth tables. Good luck with your validation. You will love using the EXM!
  20. I now have funds available for purchase of a new plasma thawer. We have always used the Helmer DH8 and have had no real problems with it - we just wore it out! I'm interested in seeing if anyone has purchased the new "Plasmatherm" made by Barkey and sold by Genesis BPS? If so, what is your impression of it? Does it thaw as rapidly as the Helmer waterbath type of thawer? I understand it only thaws 4 plasma units at a time, but how does it work with cryo? Do you lay cryo bags on top of each other to thaw more units rapidly? Is maintenance really as easy as they say?
  21. Actually, we are STILL in the process of trying to get the Trucise system all built and validated. It apparently was not created to do a label verify comparison of all 4 quadrants of the ISBT label (as the folks at Terumo originally promised it could), so we are still working with them to create workarounds to get it to do at least the donor number and ABO/Rh. We're still having issues with the product code and expiration date/time. In preparation for using the Trucise, we switched to ordering and using only supplies (bags and syringes) that have barcoded lot numbers. We were using CharterMed which has no barcodes and switched to Fenwall that does have barcodes. The other option would be to print your own little barcodes and attach them to each set or box so you have something to scan.
  22. AABB Association Bulletin #12-04 - Recommendation to Address Residual Risk of Bacterial Contamination of Platelets Dated October 4, 2012
  23. AABB Standard 5.25.5 requires a signed statement from the requesting physician. CAP requirement TRM.40770 also states that you must have records of emergency release (documented) authorization by a qualified physician. Neither make an allowance for a PA or NP or RN. It must be the physician, but there are no specified time frames for getting the signature.
  24. We also have a Helmer 8 slot and like it a lot. But... have you seen the new Genesis (Barkey) "Plasmatherm"? It looks to have a small footprint, thaws 4 units at a time, and the quote I received from Genesis is less than the new Helmer waterbath I was planning on buying. I just wish the product brochure gave estimated thaw times, because that is an important factor to consider.
  25. A customer complaint could be from anyone: doctor, nurse, nursing staff, or patient/family. They can come as email, phone call or through the hospital QA system. We also track the complaints we occasionally have with our blood supplier (delays, product shortages, mislabeled historical Ag negative units, etc). Those get reported back to the blood supplier in a report each quarter. Near misses are pretty much a judgement call on my part. I always consider... if someone would not have caught and corrected this mistake, would it have negatively impacted the safety of a patient? If the answer is Yes, I consider it to be a near miss. On our lab variance form, we have a grading key with these definitions: Grade (severity) 0 = No Grade level required: Not Applicable 1 = No clinical harm or injury to patient/staff. (Inconvenience, delay, patient redraw, customer dissatisfaction) 2 = Potential for or actual mild harm/cost. (Self-limited, recovery complete, little to no discomfort, unnecessary expense) 3 = Potential for (near miss) or actual moderate harm. (Definitive treatment required, prolonged hospital stay) 4 = Potential for (near miss) or actual severe harm. (Life-threatening, permanently disabling, death)
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