ANTIGEN PLUS V7.5 Validation Plan Rowny Systems Inc 1 OF 32
Contents
1. Heterozygous Rule Outs Single Dose Evaluation DTT Can Not Exclude E Cw K k Kpa Kpb Jsa Jsb Fya Lua Lub These are tentative rule outs Additional confirmatory data based on your own criteria are P1 rule outs 3 need at least 3 negative reactions 5 found for P 1 Xga rule outs 4 need at least 3 negative reactions 6 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 19 OF 32 Test Panel 9 Anti E K Fya Gel o 2 T File View Help Panel Anti_E_K_Fya_Enz 7 Review 1 inis Click in Results Box to indicate test _ Review2 Curent User samalone outcome evi IAT Enz DITA B C D Donor41 S Donor42 H2 Donor43 H3 Donor44 4 Donor45 5 oOo oO oOojojio DOE E DO JH pepe e ecjojt joit o O O O O D9 0 lolo o 0 0 loo Rule Outs Heterozygous Rule Outs Evaluation Enz Can Not Exclude E K Fya Fyb M N S s These are tentative rule outs Homozygous Single Dose Additional confirmatory data based on your own criteria are recommended P1 rule outs 3 need at least 3 negative reactions 5 found for P1 Xga rule outs 4 need at least 3 negative reactions 6 found for Xg2. Rh Hr Kell Duffy Kidd Lewis MN P Luh Sex Wr alb E Meo Dude 1 1 0 0 1 0 0 0 1 0 0 10 1 10 1 1 00 00 1 0 01 Rue Ot SngeDose 0 0 oj o 0 jo jo jo o 0 0 Evaluation IAT Can Not Exclude E c Cw f V k Kpa Jsa Fyb Jkb Leb P1 M N S Lua Xga These are tentative rule outs Additional rule outs 0 need at least 3 negative reactions 1 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 28 OF 32 Test Panel 18 4Anti K IAT File View Help Panel Anti K IAT Review 1 m Click in Results Box to indicate test Review 2 Current User samalone outcome IAT Ez DITA B C D oc olo og 0 Ce 0 BOO DODO 0 Additional confirmatory data based on your own criteria are recommended P1 rule outs 4 need at least 3 negative reactions 6 found for P1 Xga rule outs 2 need at least 3 negative reactions 4 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 29 OF 32 Test Panel 19 4Anti S Enz Review 1 _ Click in Results Box to indicate test Review 2 Current User samalone outcome IAT Ez DTT A B C D 14 0 14 1 A e E dei A a EJ sei _ sel sel
3. pn sl i EJ e E OO 100 0 0 oj O101010 000100101010 Eur Can list Erhai Fon R DL NI S a These are tentative rule outs Additional confirmatory data based on your own criteria are recommended P1 rule outs 7 need at least 3 negative reactions 9 found for P1 Xga rule outs 8 need at least 3 negative reactions 10 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 30 OF 32 Test Panel 20 Anti_ S IAT File View Help Panel Anti_S_IAT Review 1 n Click in Results Box to indicate test jent _ Review2 Current User samalone outcome naa Rh Hr Duffy Kidd RhHr Vial Eur ud nni OCA Deer RE IAT Ez DITTA B C D egongo 0 0 ole oe o fe 0 0 O w 0 P Xga rule outs 4 need at least db iium Ges ur MR di ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 31 OF 32 Test Panel 21 Anti U File View Help Panel Anti_U Review 1 Glick in Results Boxto indicatetest Select Patient l ARN Current User samalone outcome Supplier Donor h Hr Duffy Kai Lewis Luth Sex Wr Additional Lot RhHr Vial i Jk Jk Valdai Donor232 Anti U ij a DEBE oo em nu Luh
4. Xga rule outs 1 need at least 3 negative reactions 3 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 15 OF 32 Test Panel 5 AllPositive File View Help Panel AllPositive Click in Results Box to indicate test outcome P Luth Sex Wr Additional we Antigens IAT Enz DITA B C OD pa Pa E 2 pu pu ra ra pr 2 4 4 ot t 1 0101010 ojo Fis 4 o lolololololoi lo o lolololololololos oloooooooo o o olojlojlo j o ojo t ojloilocjtjieloi io o lojlo ojo ojlojo olo lolololololo olololololo lolo lo t e 4 e e lo m mmm T Evaluation O There is no exclusion in this panel for these antigens NO ANTIGENS CAN BE RULED OUT AS ALL CELLS TESTED ARE REACTIVE WITH THE PATIENT S PLASMA SEE TECH TIPS FOR FURTHER TESTING SUGGESTIONS These are tentative rule outs Additional confirmatory data based on your own criteria are recommended P1 rule outs 0 need at least 3 negative reactions 0 found for P 1 Xga rule outs 0 need at least 3 negative reactions 0 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 16 OF 32 Test Panel 6 Anti D File View Help Panel AllPosAutoPos Click in
5. L1 AlNegative3 0 0 i 0 0 EJ rs 14 te cO ocoococooooococcoo pr EI E the _ E E sti 4 a t m sti EI si E si ti E si cO ocoocoocooIloilocoi o OcOjojcocjololoololojioijo Homong0us Double Dose 8 3 2 99 1 2 1 0 11 0 12 0112 3 6 3 3 6 6 4 4 2 8 0 12 See oe 1 la fo o 0 o Jo 1 Evaluation Retest if P1 rule outs 9 need at least 3 negative reactions 11 found for P1 Xga rule outs 6 need at least 3 negative reactions 8 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 14 OF 32 Test Panel 4 AllPosAutoPos EE S Click in Results Box to indicate test outcome IAT Ez DITA B C OD File View Help Pane Anti_D colo oo di 4 o Ia w c ololoooo0lo o oo too ooo o ololololoclolclolol lol 0 0 0 0 0 0 Evaluation IAT Can Not Exclude D Cw These are tentative rule outs Additional data based on your own criteria are recommended P1 rule outs 6 need at least 3 negative reactions 8 found for P1
6. 11 OF ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 12 OF 32 Test Panel 1 All Negative File View Help Panel AllNegative E Review 1 i Click in Results Box to indicate test Review2 Current User samalone outcome D Kidd ews P Luh Sex Wr T Pare CREE s Aiou VAT Eu DITA B C D 1 14 Validati Donor80 DRED 10 0 4 4 4 4 _ O o EI e e pg o Bn o Ro Eo o EP o O10101 010 E e le A A E r 21 4 ojo 4 L 2 ojojo Ee eee n Xga rule outs dal at out Seen in Jia ij Click in Results Box to indicate test outcome we Antigens IAT Enz DITA B Rh Hr Kell i i MN P Luth SexWr Additional oioi oo 10 0 0 0 Kpa Fya Fyb kb Lab P1 Lua Lub Xga Cw K Fya Fyb Jkb Leb P1 Lua Xga Additional confirmatory data based on your own criteria are P1 rule outs 0 need at least 3 negative reactions 2 found for P1 Xga rule outs 0 need at least 3 negative reactions 1 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 13 OF 32 Test Panel 3 All Negative 3 File View Help Panel AllNegative3 si Click in Results Box to indicate test Select Patient Pi i outcome Supplier Lot x z IAT Enz DTTA B C D P j e Validati
7. Additional confirmatory data based on your own criteria are recommended P1 rule outs 0 need at least 3 negative reactions 0 found for P1 Xga rule outs 2 need at least 3 negative reactions 4 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 27 OF 32 Test Panel 17 Anti_ K Fyb IAT LS Es File View Help Panel Anti K Fyb IAT Review 1 Click in Results Box to indicate test Review 2 Curent User samalone outcome Supplier Donor Kell Duffy Kidd Lewis P Lut SexWr Additional Lot H RhHr Vial Antigens IAT Ge DIT A B C D Validati Donor139 Ani K Pat ai 0 0 i Donor140 2 0 ot X Jk Wi peste 0 0 3 QO 2 14 0 ee el eS Se l l lelolol ES o o 0 0 0 La 0 0 0 LE Bot ai EE 0 0 4 00 al Talol __ __ Hot 4 Validati Anti K Fyb IAT Validati Donor141 Anti K Fyb IAT 3 Validati Donor142 Anti K Fyb IAT 4 OO 100 1010l010O Validati Donor143 Anti K Fyb IAT H5 Validati Donor144 0 4 Aui KFyb IAT 86 Validati Donor145 H7 oo ocooooo Donor146 8 Validati Donor147 Anti K Fyb IAT 9 oo ocooooo Validati Donor148 Anti K Fyb IAT 10 Validati Donor149 Anti_K_Fyb_IAT_ 11 Auto Control 010 OO 00 00 0 0 lol lol 0
8. for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 32 21 OF Test Panel 11 4Anti ka secs 7 Review 1 Review2 Current User samalone Click in Results Box to indicate test outcome Duffy Kidd Lewi P Luh Sex Wr x n qu Mte IAT Em DITA B C D Jk 0 BERDRDEH 0 Di oo TI Rule Outs Heterozygous Rule Outs Evaluation No specificity detected Further testing required See tech tips for further testing suggestions Review patient P1 rule outs 5 ze Single Dose at least 3 negative reactions 7 found for P 1 2 need at least 3 negative reactions 4 found for ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 22 OF 32 Test Panel 12 4Anti ka S oto 7 Review 1 Click in Results Box to indicate test Review2 Current User samalone outcome Kell Duffy Kidd Sex Wr Additional 4 niger IAT Ec DITA B C D tit oft o sh T o cbo oo o pe ook ole ee ee ee a OO 0 4 i EI L 2 lt zi rae Additional recommended P1 rule outs 5 need at least 3 neg
9. 0 14 Heterozygous Rule Outs Evaluation E There is no exclusion in this panel for these antigens IAT Can Not Exclude E f V K Kpa Jsa Fyb Jka Lea N S s Lua These are tentative rule outs confirmatory data based on your own criteria are recommended P1 rule outs 1 need at least 3 negative reactions 3 found for P1 Xga rule outs 1 need at least 3 negative reactions 3 found for Xga Test Panel 24 Anti U Possible File View Help Panel Anti_U_Possible Review 1 Click in Results Box to indicate test _ Review2 Curent User samalone outcome AT Ge DITA B C D O There is no exclusion in this panel for these antigens IAT Can Not Exclude C E Cw f V K Kpa Jsa Fya Fyb Jka Kb Lea PI M N S s Lua Xga w Possible Anti U These are tentative rule outs Additional confirmatory data based on your own criteria are recommended P1 rule outs 0 ll di ia ca DE Xga rule outs 0 need at least 3 negative reactions 2 found for Xga
10. DITA B C OD T i 1 o 9 oooottooIoot io Oi Jojlt Joloiloilo i jo Lewis MN P Luth SexWr Jk e wr 0 03 16 0612 3 2 2 8 11 193 0 5 0 0 o jo 0 1 o o jo TREE DabeDos 5 30 37 4 1 Single Dose 0 0 Evaluation Column A Can Not Exclude E Cw K Jsa These are tentative rule outs P1 rule outs 2 need at least 3 negative reactions 4 found for P1 Xga rule outs 5 need at least 3 negative reactions 7 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 18 OF 32 Test Panel 8 Anti E K Fya Its ems File View Help Panel Anti E K Fya DTT E Review 1 Click in Results Boxtoindicatetest Review 2 Curent User samalone mdcems Duffy Kidd x P Luh Sex Wr Additional we Antigens B i IAT Egz DTTA B C D 1 O 10 IO CODE pepe oo oc 000 0 0 0 oO Jolol jJojojo t o t t O0 0101010000 090 0 B O oOojlt tjojoloilot tjojilo t oljio Validati Donor amp i E K Fya D1 13 eoo 14 _Validati Donor68 ti EKFya D 14 Auto Control
11. Select a lot number that appears on the print out for saved panel 3 and find it on the Maintain Lots screen Attempt to delete that lot Verify that you may not delete a lot that has been used in saved work Scenario 15 0 000 Log out and back in as a full user From the Panel menu load saved panel 3 and review it Confirm that after review no results can be entered then uncheck review Enter results in column A and check technologist change in the View menu Save the panel and print the results worksheet Verify that the review appears in Panel History and that prior iterations can be called up from there Clear selected cells Scenario 16 0 0 0 Log out and back in as an administrator From the Panel menu load saved panel 3 and add second review Save the panel Verify that both reviews appears in Panel History Confirm that after review no results can be entered then uncheck review Clear selected cells From the Panel menu load saved panel 3 and uncheck both reviews Add a result in any column and save the panel Verify that the old reviewed panel appears in Panel History and that it can be called up from there Clear selected cells Scenario 17 Log out and back in as a read only user Confirm that you have read only ability by attempting save selected cells Log out and back in as a save panels user Confirm that you cannot review a saved panel but can save one check Panel Hist
12. for a low incidence antigen until you find one with only one instance in the database Note the lot number Clear Search Criteria Add a panel by Lot to the selected cells and print a copy of the selected panel that contains the low incidence antigen On the Add screen mark the cell with the low incidence antigen as out of stock and capture screen to print Click on the Save button Repeat printout of select cell panel to demonstrate the out of stock cell has been removed To test the out of stock functions of the search program use the cell already marked as out of stock Run a search for the low incidence antigen on the out of stock cell and do a print screen of the message that no cells are available In systems options select Include in Searches under Out of Stock Inventory Repeat search for the low incidence antigen and print screen ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 4 OF 32 ocenario 4 Onthe Add Edit screen select a donor number from the donor drop box that appears only once in the list Bring up the cell information and do a print screen for the record Delete the cell from inventory Drop the donor drop box and type in the deleted donor number and open the list box The list should show that the number is not there and no information will populate the Add Edit screen Do a print screen to confirm this for documentation ocenario 5 Onthe Add Edit screen select a lot number from the lot
13. ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 1 OF 32 TITLE ANTIGEN PLUS VALIDATION ee Revised for Version 7 5 EFFECTIVE DATE February 17 2014 1 0 2 0 3 0 4 0 5 0 PRINCIPLE Antigen Plus is a software program designed to store and select red cells for antibody identification testing by phenotype Antigen Plus Version 7 5 is a medical device under the provisions of the FDA 510 k clearance number BK11045 In order to be used as a tool by an immunohematology reference laboratory or transfusion service the program must be validated to function as stated in the users manual after it is installed All validation testing scenarios will be performed by an experienced user Testing will be done in a database created for that purpose This database will be maintained as long as the program is in use but will not be used once validation is completed All patient data saved in the database will not use actual patient names or identifiers For instructions on creating a database for validation consult the User s Guide for an internal SQL Server installation or contact customerservice antigenplus com for a Cloud installation SCOPE RELATED POLICIES The scope of this validation plan is to assure that the program performs to specification in the laboratory setting SOPs will be developed to guide the use of the program and the required maintenance plan The program will be available to all reference laboratory
14. LUS V7 5 Validation Plan Rowny Systems Inc 25 OF 32 Test Panel 15 Anti_ K Fyb DTT sos Click in Results Box to indicate test outcome P Lut SexWr Additional yy Artigens IAT Ez DITA B C D File View Help Panel Anti_K_Fyb_DTT 4 Pr 4 O0 O0 000 0 01000 100101 1010O 7 100000 0 0 10 Double Dose 6 4 0 1 6 1 1 005042231324 00 Sngle Dose 0 0 0 DTT Can Not Exclude E K k Kpa Kpb Jsa Jsb Fyb P1 Lua Lub These are tentative rule outs P1 rule outs 0 need at least 3 negative reactions 2 found for P1 Xga rule outs 3 need at least 3 negative reactions 5 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 26 OF 32 Test Panel 16 4Anti K Fyb Enz o e File View Help Panel Anti_K_Fyb_Enz Review 1 Click in Results Box to indicate test Review 2 Current User samalone outcome Duffy Kidd IAT Ez DITA B C D 3 24 Hsisicls 0100 OPA ololololoelslols OO t oj jo t 0 04 04 00 3 1 2 2 0 10 0 Evaluation Enz Can Not Exclude E V k Kpa Jsa Fya Fyb P1 M N S s These are tentative rule outs
15. Results Box to indicate test outcome Donor RhHr Vial AT Ge DITA B C D 5 Donor186 1 Donor187 2 Donor188 3 1 1O101010 010 100 1 p 1 Donor189 4 4 t LM i 1 p ca Pr 1 Donor191 6 Donor192 7 O1010 10l0 10 0 0 0 O Donor193 8 Donor194 9 Donor195 AlPosAutoPos 10 Validati Donor196 AlPosAutoPos sti Auto Control 2 T o o o o o o o o o O oO jojoj jojlojlojojo o 1 Oo o1 0o0 01 10 0 0 0 0 0 0 oO o o o o o o o o o o 010101001000 100 O I 10101010 100 Homozygous Rule Outs Heterozygous Rule Outs Evaluation 3 There is no exclusion in this panel for these antigens NO ANTIGENS CAN BE RULED OUT AS ALL CELLS TESTED ARE REACTIVE WITH THE PATIENT S PLASMA SEE TECH TIPS FOR FURTHER TESTING SUGGESTIONS These are tentative rule outs Additional confirmatory data based on your own criteria are recommended Auto Control Warning Possible autoantibody present Ba DRE Re Den i i ee ri ds P1 rule outs 0 need at least 3 negative reactions 0 found for P1 ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 17 OF 32 Test Panel 7 4Anti E Cw gel 7 Review 1 Click in Results Box to indicatetest Review2 Current User samalone outcome Kell D Kidd 1 IAT Ez
16. Sex Wr Homozygous _ RueOus Double Dose Heterozygous Rule Outs Single Dose Evaluation 3 There is no exclusion in this panel for these antigens IAT Can Not Exclude D C E Cw f V K Kpa Jsa Fya Fyb Jka Jkb Lea P1 M N S s Lua Xga These are tentative rule outs Additional confirmatory data based on your are recommended P1 rule outs 0 need at least potes met d found for P 1 Xga rule outs 0 need at least 3 negative reactions 1found for Xga Test Panel 22 Anti U Absent File View Help Pane Anti_U_Absent Review 1 Click in Results Box to indicate test Review 2 Curent User samalone outcome Kell Duffy Kidd IAT Ee DITA B C D T_14 0 9 There is no exclusion in this panel for these antigens IAT Can Not Exclude D C E Cw f V K Kpa dea Fya Fyb Jka Kb Lea P1 M N S s Lua Xga rule outs ory data based on your own criteria are recommended tuali il Salis clie r PE rule outs 0 need at least 3 negative reactions 1 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 32 OF 32 Test Panel 23 Anti U Absent2 File View Help Pane Anti_U_Absent2 Review 1 Click in Results Box to indicate test Review2 Curent User samalone outcome P Luh Sex Wr Additional IAT Ec DITA 8B C D Tne T T 1 0 nt 0
17. a ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 20 OF 32 Test Panel 10 4Anti E K Fya IAT File View Help Panel Anti_E_K_Fya_lAT E Review 1 ate m Click in Results Box to indicate test Review 2 Current User samalone outcome Kell D Kidd Lewi rx lar ces j IAT Ez DITA B C D og 10 0 eme 0 Validati Donor27 j E K Fya IA 1 Validati Donor28 wi E K Fya IA 2 Validati Donor29 i E K Fya lA 3 Validati Donor30 pti E K Fya IA 4 Validati i E K Fa A Validati nti E K Fya IA Validati i E K Fya IA Validati L o oo oo fo 0 H e i Oc t Jlol ojoloilortlojilo t o jo oo oc oO tr Oo 0 Oo AERE EE Ed Ed 4 ose o l lo 0 O0 001010 O1O0101010 000110 T E EA E ng Ea 01010000 010 El c bal oOjojoOjolt Jojo t oO o Bn DE Homo Ruedas Double Dose 2 1 0 3 4 2 1 0 Haaga Snge Do Evaluation IAT Can Not Exclude E Cw K Fya Jkb These are tentative rule outs P1 rule outs 2 need at least 3 negative reactions 4 found for P 1 Xga rule outs 2 need at least 3 negative reactions 4 found
18. all electronic information of all RBCs as they are received by the lab must be shown to contain the correct donor lot supplier and expiration date after entering the program database 3 Out of stock designation assigned when a cell has been used to exhaustion or as they are discarded must be shown to not be presented on a selected cell panel with the out of stock cell or appearing in the lot printout 4 Deletion of individual cell information to correct an incorrect entry or if a sample will never again be available to the reference lab must be shown to remove the cell s phenotype information 5 Deletion of an panel not used in a saved work up by lot must be shown to delete every cell listed in the loti 6 Cell selection by phenotype must be shown to be consistent 7 All print functions must be shown to provide the correct information 8 Out of date function must apply itself automatically when required 9 Program must maintain correlation between Wiener phenotypes and Hh antigen typing as described in the user manual 10 Test the save function by reloading the panel and compare printouts 11 Show that the program can differentiate between frozen inventory and liquid inventory by selected searches 12 Using 3 specificities where 1 is destroyed by enzyme treatment 1 by DTT and 1 not affected put the probable reactions in the IAT DTT and ENZ columns of the results panel Print the results to include all the evaluations and h
19. an remove someone else s review or edit patient data 15 Testing history is be maintained by user and date accessible in the Results Worksheet View Menu under Technologists and Panel History 16 All test panel results should agree with the images provided RESULT REPORTING All documentation produced by the validation scenarios will be saved as part of the program s validation record LIMITATIONS As with any software program it is only as good as the staff that maintains it Maintenance is critical to the function of the program A hazard analysis will be developed based on all information gained while performing the program validation in the laboratory setting REFERENCES AABB Technical Manual 17 Edition ch 16 pg 470 1 Standards for Immunohematology Reference Laboratories 6 edition Bethesda MD The data in the original printout and the data in the printout produced from the same panel being saved and reloaded will be identical Standards for Blood Banks and Transfusion Services 26 edition Bethesda MD American Association of Blood Banks 2009 User s Manual Version 7 5 Antigen Plus Rowny Systems Inc Gaithersburg MD 2013 ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 10 OF 32 DATE DATE DATE DATE oignatures on file ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 32 WORK RECORD PERFORMEDBY gt DATE REVIEWED DATE ACCEPTEDBY DATE SIGNATURES ON FILE
20. and select load selected panel Choose the panel saved and click on load The number of cells selected at the bottom of the Search screen should now read the same as contained in the panel printout from the first step Print out the screen and document any unexpected findings On the search screen select clear selected cells then repeat the steps above using a new patient name dob and identification number and saving the panel with the number 2 ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 6 OF 32 scenario 11 Change the status of one of the panels in stock from liquid to frozen by using the frozen button on the Add edit screen Each cell must be changed individually Save the change Go to the Search screen and do a search for frozen cells only The entire lot of cells frozen should be presented for selection Select them all and print the select cell panel resulting from the search All cells should be marked FZN No other cells should be presented in the search Switch to the Results panel and print a copy All cells in the Results Worksheet should still carry the FZN designation in the far left column Document any inconsistencies Scenario 12 Using selected panel 1 from Scenario10 above Fill in results in the IAT column for 3 specificities I e K Le Fy 1 that is destroyed by enzymes 1 by DTT amp 1 not affected Fill in the appropriately altered results in the ENZ column and the DTT co
21. ata should be reproduced in exactly the same manner and contain identical information if selected in exactly the same manner 6 Cell information must be identical whether the cell appears on a lot panel or on a Result panel All print functions should print the information required in the correct format and there must be no altering of data between formats 7 The out of date designation will appear when appropriate and be noted on the results panel and on the Search screen 8 All Weiner phenotypes will produce the correct antigen types when selected 9 The data in the original printout and the data in the printout produced from the same panel being saved and reloaded will be identical 10 Only frozen cells will appear in the search results and the printout will carry the FZN designation for each frozen cell The results panel used to test these cells will also show the FZN designation 11 The Evaluations must be correct according to the Exclusion Policy located under Help opecifically there may be no exclusions of K under DTT testing and no exclusion of Fy under ENZ testing 10 0 12 0 ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 9 OF 32 12 The Evaluations must show that for Scenario 13 in the first printout K Kp and Js were properly ruled out and accurately counted and that in the second printout none of these were ruled out 13 All patient data will be maintained with saved panels 14 Only an administrator c
22. ative reactions 7 found for P1 Xga rule outs 4 need at least 3 negative reactions 6 found for Xga ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 23 OF 32 Test Panel 13 Anti K DTT so 7 Review 1 s Click in Results Box to indicate test Review 2 Current User samalone outcome Kell Duffy Kidd Lewis MN P Lut Sex Wr Additional K Je o o lea o Bal olo go Fy joy E IAT Ez DITA B C OD 14 4 t olololololololololo 0 0 0 0 0 2 5 6 3 55 3 6 2 6 0 0 0 Xga rule outs did ok ei dace dien Eee Mni ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 24 OF 32 Test Panel 14 Anti_ K Enz 7 Review 1 _ Click in Results Box to indicate test Review2 Curent User samalone outcome Duffy Kidd Lewis IAT Ez DTA B C OD 0 0 2 14 Enz Can Not Exclude K Fya Fyb M N S s These are tentative rule outs Additional confirmatory recommended P1 rule outs 4 need at least 3 negative reactions 6 found for P1 Xga rule outs 2 need at least 3 negative reactions 4 found for Xga data based on your own criteria are ANTIGEN P
23. by returning to the Options menu and selecting Antigen Display Order numbers for the other commercial suppliers and returning to the Results Worksheet and selecting Print at the top of the screen Compare the printed copy to the information on the screen Note any discrepancies From the main screen drop the lot drop box and select one of the lot numbers on the Results Worksheet Use the print lot panel on the File drop box list to print this panel Compare the cell data between the Results Worksheet printout and the lot printout Document any inconsistencies ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 5 OF 32 Scenario 8 Scenario 9 In the search screen select an out of date panel from the list of lot s Verify that upon selection of an out of date cell or cells the Review Selected Cells screen appears and click Review on one cell From the Cell testing History screen drop down the list of retested antigens check one or more and save changes verify that these antigens now appear in the Antigens Retested list Print the selected cells and note the OOD designation in the far left column Go back to the search screen and clear selected cells when this step is complete Select the same panel again and verify that the retesting changes you made have been maintained with today s date From the Add edit screen change the expiration date on the panel to one that is now in date F
24. drop box Bring up the cell information on a select cell panel and print it for the record Delete the lot using the Delete Lot button on the bottom of the screen Drop the lot drop box and type in the deleted lot number and open the list box The list should show that the number is not there and no information will populate the Add Edit screen Do a print screen to confirm this for documentation Using the select cell panel printed in the first step try to select at least 3 of the cells on the panel by donor number and confirm that they are no longer in the inventory attached to that lot number ocenario 6 Use the following a C K Js a 2 examples b D K Js a 2 examples c C K JS a 2 examples to construct a select cell panel Select the first 2 cells presented with each request Go through the process 5 times Each time print the select cell panel When all 5 panels are printed do a line by line examination to ensure that the program presented the same 6 cells in the same order and that they match the requirements set ocenario 7 From the Systems Options menu select Antigen Display Order for Search select Biotest and using one of the previous select cells panels from Scenario 5 go to the Results panel through the File drop box Add 0 for a negative result in all the IAT column boxes for the 9 cells selected and then select Print at the top of the screen Repeat this printout 6 times
25. lumn Print the results worksheet to include all the Evaluations Manually assess the Evaluations for correctness according to the Exclusion Policy located under Help Document any discrepancies Manually count the total number of examples of each time an antigen has been found non reactive Document any discrepancy Clear selected cells Scenario 13 On the search screen choose Select Patient and enter name dob and identification number for a patient Create a panel with heterozygous positive specificities for K k Ko Kp and Js Js one example of each Add three more cells with homozygous specificities for K k Kp Kp and Js Js one example of each In the IAT and ENZ columns enter a negative result for each of the heterozygous entries Print the results worksheet to include all the Evaluations In the IAT and ENZ columns enter a positive result for each of the homozygous entries Print the results worksheet again to include all the Evaluations Manually count the total number of examples of each time an antigen has been found non reactive in both printouts Document any discrepancy Choose the View menu for the Results worksheet and verify that technologist and testing date for the result columns match the information on the print out Save the selected panel with results numbering it 3 Clear selected cells ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 7 OF 32 Scenario 14
26. ory to verify ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 8 OF 32 Scenario 18 This installation disk or Validation database in the Cloud version contains sample lots for validation testing These are the same lots used for our internal unit testing and are carefully selected to exercise all parts of the evaluation code To use these files 1 Use the File gt Import Data command in Antigen Plus to import the PNL files in this folder this step is not necessary for the Cloud version 2 Search for one of the lots by name select all cells and open the Results Worksheet from the Panel menu 3 Enter the same test results in Antigen Plus that you see in corresponding Test Panel image reproduced below pp 12 31 4 Verify that the rule out counts and evaluation text are the same as in the image Close the Results Worksheet and clear the selected cells 6 Repeat steps 2 6 for the other lots d 9 0 INTERPRETATION Acceptable result criteria 1 There will be no difference between the supplier antigram and the program printout by lot once the panel has been transferred electronically into the Antigen Plus database 2 Once marked out of stock the cell s with the low incidence antigen should not appear in a Search or on the panel printed by lot number 3 Once deleted there should be no record of the donor in the program 4 Once deleted there should be no record of the panel lot in the program o All identical d
27. ow many examples of antigens had been nonreactive when tested ANTIGEN PLUS V7 5 Validation Plan Scenario 3 Rowny Systems Inc 3 OF 32 ocenario 1 Following directions in the User s Guide create user accounts with passwords to cover all permission levels Log in and out changing users Return to original user log in with administrator level ocenario 2 Download 10 cell commercial lot from each of the commercial suppliers that you use until you have 5 panels Do the same for 3 screen cell lots f you use or plan to use Immucor panels check the SUT box when downloading and select some additional antigens from the list to include on your download When doing the line by line comparison of the data check against the SUT sheet from Immucor to make sure your selections have been added in the proper places You may delete one of these lots and download it again with different criteria to double check Use the print lot profile function on the lot drop menu to print a copy of each lot added to the database Do a line by line comparison of the data on the printout compared to the data in the antigram from the supplier Document any variations Sign and date the Antigen Plus copy once it contains exactly the same information as the antigram Keep both copies as user testing documentation Capture Systems Options settings to show out of stock not included in Search Capture screen to show cell marked out of stocks Search
28. rom the search screen print the selected cells either from the Preview Selected Cells button or by opening the Selected Cells Worksheet in the Panel menu Compare the first printout to the second one and look to see if the OOD designation no longer appears on every cell of the date altered panel oave all printouts and document any inconsistency Using the Add edit screen clear the page as if to enter a new cell Go to the Rh Hr drop box and select a Weiner phenotype Check to see if the antigen typing results that appear are correct for the phenotype selected Create cell entries starting with RH1 through RH36 with a common lot number to prove that all the Weiner phenotypes produce the correct cell typings in the Rh Hr section of the common typings When a typing does not appear and there is a flag stating no typing results are associated with the phenotype print screen to confirm Print the panel by lot number and review for any discrepancies Document findings Scenario 10 On the search screen choose Select Patient and enter name dob and identification number for a patient Create a panel to exclude anti E and save the panel using the save selected panel with a panel number 1 Print the Results Worksheet before closing it On the search screen select clear selected cells The number of cells selected at the bottom of the Search screen should now read O Do print screen to document Go to the panel menu drop the box
29. technologists including staff rotating through the special testing areas SPECIMEN N A MATERIALS A minimum of 50 different RBC samples from commercial suppliers The mix should consist of 5 commercial panels from any supplier used by the lab is to be downloaded electronically from a website and stored on the end user s system One panel should be out of date For an internal SQL Server installation the Validation Lots folder on the installation disk For the Cloud the validation lots supplied on a requested validation database SAFETY Compliance with Laboratory Quality Practices Bloodborne Pathogens Employee Exposure Control Plan ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 2 OF 32 6 0 RECORDS FORMS DOCUMENTS 7 0 8 0 User testing documentation of program activities will consist of select cell panels and panels printed by lot number to be compared with the corresponding antigram provided by the panel supplier The results of all validation testing will be printed directly from Antigen Plus ocreen capture pictures will be printed to demonstrate warning flags and necessary screen information QUALITY CONTROL N A PROCEDURE The following is a list of functions that must be validated before being used by the laboratory staff to create select cell panels and evaluate test results Test case scenarios will be developed to cover the following 1 Verification of user log in and permission status 2 Entry of
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