SMILE Johns Hopkins University Baltimore, MD USA Westgard Rules - Guidelines Guideline um!

er E''e(tive Date Author Heidi Hanes Su!-e(t "a/e .est/ard 0ules Guidelines

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SMILE 1omments2 3his do(ument is provided as an e4ample only5 It must !e revised to a((urately re'le(t your la!6s spe(i'i( pro(esses and*or spe(i'i( proto(ol re7uirements5 Users are dire(ted to (ounter(he(k 'a(ts 8hen (onsiderin/ their use in other appli(ations5 I' you have any 7uestions (onta(t SMILE5

What are Westgard Rules?

.est/ard 0ules are multirule 91 rules to help analy:e 8hether or not an analyti(al run is in%(ontrol or out% o'%(ontrol5 It uses a (om!ination o' de(ision (riteria, usually # di''erent (ontrol rules to -ud/e the a((epta!ility o' an analyti(al run5 .est/ard 0ules are /enerally used 8ith ) or ; (ontrol measurements per run, 8hi(h means they are appropriate 8hen t8o di''erent (ontrol materials are measured & or ) times per material, 8hi(h is the (ase in many (hemistries appli(ation5 <or hematolo/y, (oa/ulations, and immunoassays appli(ations some alternate (ontrol rules are more suita!le 8hen three (ontrol materials are analy:ed5

Explanation of Individual Rules

12s =ne (ontrol measurement e4(eedin/ ) standard deviations o' (ontrol limits either a!ove or !elo8 the mean5 3his rule is used a 8arnin/ rule to tri//er (are'ul inspe(tion o' the (ontrol data5 13s 3his rule is (ommonly used 8ith a Levey%Jennin/s (hart 8hen the (ontrol limits are set as the mean >? standard deviations o' (ontrol limits5 A run is re-e(ted 8hen a sin/le (ontrol measurement e4(eeds the mean >? (ontrol limits5 22s 3he (ontrol run is re-e(ted 8ith ) (onse(utive (ontrol measurements ) standard deviations o' (ontrol limits on the same side o' mean 8ith this rule5 R4s 3his rule re-e(ts a run i' t8o (ontrol measurements in a /roup e4(eed the mean 8ith a ; standard deviation di''eren(e !et8een the ) (ontrols 41s 3his rule re-e(ts a run 8ith the ;th (onse(utive (ontrol measurement e4(eedin/ & standard deviation on the same side o' the mean5 10x 3his rule re-e(ts a (ontrol run 8hen there are &$ (onse(utive (ontrols on the same side o' the mean5

o! to perfor" "ultirule #$
3o per'orm multirule 91 (olle(t your (ontrol measurements in the same 8ay as you 8ould 'or a re/ular Levey%Jennin/s (ontrol (hart@ esta!lish means and standard deviations 'or the (ontrol materials@ then (reate a Levey%Jennin/s (hart 8ith the mean >?, >), and >& standard deviations5 3he only di''eren(e is the interpretation o' the data5

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SMILE Johns Hopkins University Baltimore, MD USA

3he 12s rule is used as a 8arnin/ to tri//er appli(ation o' the other rules5 Any time a sin/le measurement e4(eeds a ) standard deviation (ontrol limit, you respond !y inspe(tin/ the (ontrol data usin/ the other rules5 3his doesn6t mean stop, it -ust means to look (are'ully at the data !e'ore pro(eedin/5

By usin/ the 'ollo8in/ dia/ram you should !e a!le to de(ide 8hat i' any a(tion is re7uired5

1ontrol Data

12s o

In-&ontrol Report Results In%1ontrol 0eport 0esults

Ees

no

no 13s yes 22s

no R4s yes

no 41s yes

no 10x yes yes

=ut%o'%(ontrol, 0e-e(t analyti(al run

Wh% use a "ultirule #$ pro&edure?

3he advanta/es o' multirule 91 pro(edures are that 'alse re-e(tion (an !e kept lo8 8hile at the same time maintainin/ hi/h error dete(tion5 3his is done !y sele(tin/ individual rules that have very lo8 levels o' 'alse re-e(tion, then !uildin/ up the error dete(tion !y usin/ these rules to/ether5 It is like runnin/ t8o liver 'un(tion tests and dia/nosin/ a pro!lem i' either one o' them is positive5 A multirule 91 pro(edure uses t8o or more statisti(al test, C(ontrol rulesD to evaluate the 91 data, and then re-e(ts a run i' any one o' these statisti(al tests is positive5

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SMILE Johns Hopkins University Baltimore, MD USA

'ther &o""on "ultirules used for anal%(ing 3 different &ontrols

2of32s <or this rule re-e(t a (ontrol i' ) out o' ? (ontrol measurements e4(eed the same mean >) or %) (ontrol limits5 31s <or this rule re-e(t 8hen ? (onse(utive (ontrol measurements e4(eed the same mean >& or %& (ontrol limits5 )x <or this rule re-e(t 8hen , (onse(utive (ontrol measurements o' one (ontrol 'all on one side o' the mean5

Referen&e
.est/ard J=, Barry "L, 9uam E<, Shrmeyer SS, "laut D, Statland BE5 1hapter , in Basi( 91 "ra(ti(es, 3rainin/ in Statisti(al 9uality 1ontrol 'or Health(are La!oratories, ) nd Edition, .est/ard 91, In(, Madison, .I, )$$), ppFF%++5

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