PEPFAR Quality Control and Method Validation Activity 9: Part 4

ISO 15189:2012 - 4.9 Identification and control of On-going Evaluation of Your Quality Control Systems Documentation of the Analytical System nonconformities ISO 15189:2012 - 4.9 Identification and control of .SO 2012 and , SO 2012 and .SO 2012 and ot .SO ISIS9 2012 Identification and control ot .SO ISIS92012 4.9 Identi"cat.on and control ot 131S9 2012 Identification ana control ot Gaussian is the Key to Quality Control Control Activity: QA Officer Needs Your Help! Documentation of the Analytical System Documentation ot the Analytical System nonconformities a) the responsibilities and authorities for handling nonconformities are Every laboratorian who operates a method Every laboratorian who operates a mnethod Every laboratorian who operates Puroose Purpose What VOu do? What need? What VOU do? What VOU Every laborator•an who operates a rnethod Every laborator•an who operates a mnethod Every who operates a rnethod Every laborator:an who operates a rnethod Every laboratorran who operates a rnethod Every laboratorian who operates a rnethod designated; has the responsibility to record has the responsibll•tv to record has the responsibil•tv to record has the responsibil•'tv to record has the respons•bilhtv to record has the responsibliRv to record has the responsibilhtv to record has the responsib'hitv to record has the responsjbilh:tv to record has the to record has the responsibilatv to record • anv changes made to the system • anv changes to the setenn • anv changes mnade to the system • anv changes rnade to the • anv changes to the sestern • anv changes to the sestenl • any changes rnade to the svstemn • anv changes to the • anv changes rnade to the svstem • any changes to the svstenn • anv changes to the svstem • anv changes ade to the • anv changes to the svstenl • any changes mnade to the systemn • anv changes to the svstern • any changes made to the system • anv changes to the system • anv changes to the sssteml has the responsibility to record has the responsibil•tv to record Ghas the responsibll•tv to record has the responsibilitv to record b) the immediate actions to be taken are defined; Standard: "The laboratory shall • contro' results obtained during operation • controU results obtmined operation • contro' results obtained operation • control results obtained operation • control results obtained during operation • contro' results obtained duing operation • decvsions on reporting or not reporting • decsions on or not reporting • decsions on reporting or not reporting • decos•ons on reporting or not • dec•sions on reporting or not reporting • decosvons on report•ng or not • decosvons on reporting or not reporting • decisvons on repor ting or not reporting • decos:ons on or not reporting • decis•ns on or not reporting • decvs•ons on reporting or not revorttng • dees•ns on reporting or not • dec•svons on reporting or not • decvs'ons on or not reporting • decvsions on reportane- or not reporting • dec•szons on reporting or not reporting • decvsions on or not reporting • decasLons on reporting or not reporting • decsons on or not reporting • decjs'ons on reporting or not reoortlng • dec•sLons on not reporting What need? • on reporting 0' not reporting • decas•ons on repor ting* or not reporting • on reporting 01 not reporting • on reporting or not report•ng • decisions on reporting or not reporting • on reporting or not reporting • on reporting or not reoortlng What What you need? c) the extent of the nonconformity is determined; Key Message Key Messag • any changes made to the system • any changes made to the svstem • anv changes made to the system • anv changes ade to the • anv changes made to the svstem patient test results patent test results Alerts us to changes in Monitors and evaluates Mcnitors and evaluates • corrective action taken • correctave action taken • correctwve action taken • correctue action taken d) examinations are halted and reports withheld as necessary; d) examinations are halted and reports withheld as • correctwe action taken • correctuve action taFken • correctuve action taken accuracy and precision select appropriate control rules method performance • control results obtained during operation • control results obtained duriIng operation e) the medical significance of any nonconforming examinations is e) Rhe meclicai significance of any nonconforming examinations is To document effectively, we must record the Levey-Jennings Graph 200.0 Key Message information as events occur. Key Messages considered and, where appropriate, the requesting clinician or Messages • decisions on reporting or not reporting • decos•ons on reporting or not 201 s 201 is before 201.0 authorized individual responsible for using the results is informed; auf00ri4ed Individual responsible for using the results is informed; auth01 ized individual responsible for using the results is informed; O- 201.0 203.0 200.0 mean con patient test results t test results shift requitemenis before mean can f) the results of any nonconforming or potentially nonconforming f) the results o any nonconforming or potentially nonconforming f) 'he results of any nonconforming or potentially nonconforming mean 189.0 199.0 exceeded using ékfflinations already released are recalled or appropriately 199.0 198.5 requitemenfs Target ace 1 TEa TEa TEa examinations already released are recalled or appropriately s alread released are recalled or appropriately requirements before 'enchmachiry methods using Total Error Error • corrective action taken • correctwve action taken ctive action taken me+hds using genchrnarhing using genchmarhing using genchmarHiD3 mef+,oås using genchrnarHiD3 methods using using meenoås using mefhoås using ace Determine if the system is scale allows a. laboratory identified, as necessary; scale allows scale allows laboratory genchmar6iD8 mefhods using genchmar6iry methods using genchmarhinj met-hods using me+hods using genchmac6in9 me+hods using Defines an acceptable change vs. scale stable or undergoing a uc:e resources Sigma scale allows ug resources resources Sodium g) the responsibility for authorization of the resumption of I 'jaccept'3'ol åange (TE < TEA) scale allows scale recordKeepiry9 is essen+iat in recordKeepin,9 is essen+ial in recordKeepini9 is essen+ial recor-dHeepIn9 is essen+ial recordHeepin9 is essen+ial recordHeeP103 is essen+ial recordKeeplr,9 is essem< unacceptable change (TE < TEA) change by comparing today's Sodium ug teeøurces ug resources use resources examinations is defined; resources tesdvir,9 QC tesdviry QC tesdviny QC QC To document effectively, we must record the C-ooå recordKeepin9 IS essen+ial in observed value with the past observed vawe with the past recordKeeplry is essen+ial in recor-dKeep'lß9 IS essen+ial recordKeep•rn9 is essen+ial in recordKeepi09 IS essen+ial in Use SEC or Sigma to benchmark o,- Sigma to benchmark h) each episode of nonconformity is documented and recorded, with each episode of nonconformity is documented and recorded, with history of previous results tesdviny QC QC information as events occur. methods and select Potassium these records being reviewed at regular specified intervals to detect trends and initiate corrective action. trends appropriate control rules 30 31 32 28