Dansket

We use Alba QChek controls for ProVue. Alba Q-Chek Simulated Whole Blood Controls comprises of a set of 4 x 6mL whole blood samples. Sample A is a pool of Group A Rh Negative (rr) and contains anti-B and anti-D. Sample B is a pool of Group 0 Rh Positive (RIR1) and contains anti-A, anti-B and anti-c. Sample C is a pool of Group B Rh Positive (Rlr) and contains anti-A. Sample D is a pool of Group A2B Rh Positive and contains no other antibodies. We use all 4 samples to perform Daily QC on the A/B/D Monoclonal and Reverse Grouping card, Anti-IgG Gel card, Buffered Gel card and the A/B/D Monoclonal Grouping card on ProVue.

I'm using Meditech C/S 5.67 also. To understand your need, please define "call box". What do you want the user to see on-screen if "call box" is activated? For example, these lines of code at the end of your antibody screen calculation would cause the message "Antibody Screen is Positive!" to be displayed: "Antibody Screen is Positive!"^MSG1 [f bres set abs interp](X), IF{X="POSITIVE" [f bbk err msg](MSG4)};

FDA references the term "computer crossmatch" in the USA.

Is anyone in this thread doing computer crossmatch? If so, my approach is different in that I use a single crossmatch test that includes individual tests for IgG Gel and Buffered Gel crossmatches. If patient qualifies for computer crossmatch Medtech C/S 5.67 enters "NP' for both tests and interprets the crossmatch as compatible. If patient does not qualify for electronic crossmatch, both serological crossmatches (-IgG Gel and Buffered Gel) on ProVue.

Interesting, those of us doing electronic crossmatch would never see this.

Contact your ORTHO salesperson

Buffered Gel cards have same expiry date as other cards but may not be cost effective for you. I also use my Buffered Gel cards for Immediate-Spin crossmatch and testing with liquid Anti-A,B (ABO confirm of donor rbc units labeled O POS).

Goodchild, I don't use the PolyDAT gel card. In response to a request/need for DAT on adult, I use the anti-IgG card and a buffered gel card. Liquid anti-complement reagent is added to buffered gel card and incubated 10 minutes with patient rbcs, centrifuge and read. Results are reported separately for anti-IgG test and anti-complement test.

I don't understood the rationale for using a less sensitive methodology (Tube Test DAT) to invalidate the results of a more sensitive methodology (Gel-DAT). An auto-control (rbcs+plasma+37C incubation=Indirect Antiglobulin Test) and a DAT (rbcs only - no incubation=Direct Antiglobulin Test) are different tests and I don't expect them to agree 100% of the time (having done gel testing continuously for past 11 years). Auto-control is not a reportable result. If the Gel-DAT (anti-IgG card) is positive, I report DAT-Positive regardless of the auto-control results. Just my 2 cents!

Although we implemented the EXM, all Type and Screens are processed identically, whether or not blood components are requested. A second venipuncture is done on all patients who do not have a blood type on file (excluding prenatal ABO,Rh and Antibody screen requests) and whose initial blood sample is not agglutinated by anti-A,B.

Tropitronics is the US distributer and servicer of the Canadian Ark Bio Plasma Defrosters that are FDA approved. These unit have been available in the US at least since 1990's.

HFAP headquarters determined that we do meet the intent of the standard. So no deficiency cited or on record. Thanks for you replies!!

I don't run controls (pos or neg) with the crossmatch test on ProVue. I run pos and neg controls for the Buffered Gel card and the Anti-IgG gel cards that are used for crossmatching, but not the ProVue crossmatch tests themselves.

Our daily ProVue instrument QC report generated as a Batch Listing typically takes 7-8 pages. We use preprinted paper in the ProVue printer which is imprinted in the header: "Reviewed______page(s) of _____ Date:________ By:____________". On completion of the review it reads, "Reviewed 8 page(s) of 8 Date: 4/16/2016 By: Dansket" or "Reviewed 2 page(s) of 2 Date: 4/16/2016 By: Dansket" on the first page ONLY. I do not sign/date/initial the other pages. At our latest HFAP inspection April 2016, the surveyor recommended that each page be signed. We were not cited for this. This was not an issue (citation or recommendation) by the previous surveyors in 2012 and 2014. Is there any regulation by any other accrediting agency, public or government, that would cite me for the above practice? If so, please provide pertinent section #'s etc.

Not being able to utilize partially-used cards is a BIG deal! If you run a single Type and Screen (two cells) specimen, VISION will only use 2 of the 6 Gel columns leaving 4 Gel columns unused in that Anti-IgG Gel card. If I understand correctly, that partially-used (2 of 6 wells used) Anti-IgG Gel card cannot be used for testing any blood sample! The 4 unused wells are wasted and must be discarded. No so with ProVue.

We use flowcharts if the electronic P/P is not available.

I use a commercially available QC package containing anti-c and anti-D that reacts 3-4+ with my screening cells. Almost all of the positive antibody screens that we detect react <3+. So I'm not concerned about detecting weakly reactive patient antibody given that Gel eliminates many of the variables associated with tube testing that can result in failure to detect weakly reactive patient antibody.

Thanks for all your ideas! I plan to contest this. Will post outcome.

Dispense some saline into a clean tube. Observe for clarity and presence of any "floaters". Document this activity on a daily basis.

When performing tube testing, tubes are read for the presence/absence of agglutination. Results of these observations are documented in computer/on paper. Tubes are discarded. At that point, what direct proof do you have that the tubes were graded correctly and results entered correctly in computer/on paper? The only proof was in the contents of the test tube and it is gone! When an audible alarm system is tested, the only proof is the brief sounding of the alarm and then it's gone too!

Scott.. Do I understand correctly, that your process for determining the temperature of audible alarm activation is based solely on a reading taken from the temperature chart pen tracing? Dan

This is the HFAP requirement: 08.01.05 Blood and Blood Product Storage. Blood and blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (2) Inspections of the alarm system must be documented. §493.1271(c)(1)(2) This is the inspectors citation of deficiency: This standard is not met as evidenced by the following: "Review of records and interview with staff and Biomed revealed alarm testing is being performed quarterly. However the blood bank refrigerator charts do not reflect any spikes and there was no documentation on the charts that indicated that there were no checks". Her first sentence acknowledges that we are doing quarterly alarm testing. In her second sentence, she states that the lack of "spikes" suggests that we are not doing quarterly checks, hence the citation of deficiency. I'm chaffing at the bit because I believe the FDA requires that the audible temperature alarm system be tested regularly. I don't see the temperature chart recorder as part of the Audible Temperature Alarm system. We use a digital thermometer (Fluke) to monitor the temperature of the liquid as it approaches and exceeds the 1.5C and 5.5C set points. A digital thermometer will respond to temperature changes in milliseconds, whereas a temperature recording chart pen takes seconds to respond to temperature change. Once the audible alarm sounds the alarm probe is immediately returned to 4C liquid and as a result, no spike in the tracing. I understand that attempts to correlate the temperature chart recording with the audible alarm sounding as being one tactic for controlling the process, but not being prescribed by an inspector as the only acceptable method. Our temperature charts are printed in one (1) degree intervals. You can't read a temperature chart to a tenth of a degree! We record this reading each day as a whole number (no fractions). We record the digital temperature display each day in the format n.n. Again I believe the purpose of alarm testing is to verify that the audible alarm is sounded if the temperature sensed by the probe reaches the alarm set points. It is not to check the calibration of the temperature chart recording pen! Say you?

Just what are the advantages of an 8-well card. I saw a picture of a card for ABO/Rh and reverse grouping that had additional wells with anti-A,B and anti-CDE. Don't see the extra bang for the buck with that card!

Does VISION use both MTS Diluent 2 and MTS Diluent 2+?

If you observe your chemistry, hematology and coagulation departments that use automation, you will commonly see that automated instruments have automated instruments as back-up. Consider this as you move forward with automation.