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1. Knowing now matters The following information in this presentation is intended as an aid in the development of your facility s QCPs Specific requirements for QCPs can be found from CMS and your accreditation organization FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED n Agenda 1 Where are we right now 2 What to expect from the Inspectors Pen to Paper suggestions What you can do right away Risk Assessment Quality Control Plan Quality Assurance Plan 4 Let s do a practice IQCP F QCP Helpful Hints Our goal is to get you started on your IQCPs Where are we right now FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 2 ud CLIA QC Options Default 2 3 levels external QC day Jan 1 2016 EQC GE on EIKE ee COLA CAP M Joint an FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED What to Expect from Inspectors FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED Not the Conclusions ee EE The Process Was the IQCP developed with input from the right personnel Were the data used in the RA of reasonable quantity and quality Is your data summarize in an easy to read format Is there a process to monitor and review quality performance and linked back to RA FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED fa IQCP SOP is not required by CMS but should be considered as good laboratory practice and m
2. Link your existing and new QC processes to the failures they prevent or detect Examine all your QC processes If you find a QC process that does not prevent or detect a failure use the IQCP process to stop doing it FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 31 PA Process and Procedure Controls Equipment Maintenance and Corrective Actions Temperature Records Personnel Training and Equipment Calibration Records Competency Assessment Verification Data or Establishment of Performance Specification Data External Controls FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 32 fl When Using External Controls You Must Specify Criteria FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 33 External Controls FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 34 Quality Assessment QA Monitoring must be part of the laboratory s overall Quality Assessment plan The monitoring should include but is not limited to testing personnel environment specimens reagents and test system Reevaluation of the QCP should be considered when changes occur In any of the above components or during a failure investigation QAis used to determine if the quality activities are working according to your QCP Personnel Competency and Training Records of Preventative Maintenance amp Corrective Actions PR ouaiity Assessment Activities Quality
3. Control Proficiency Testing Review of Process and Procedure R Controls Results Provider Complaints Specimen Rejection Logs FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 36 Without Quality Assessment p You Don t Have a Complete IQCP 3 Risk Implement the PLAN with a review li schedule for evaluating your QCP hee Assessment Is it kina Has anything Monitor verify and improve eh eee gone wrong the PLAN when needed You must update any portion of the RA with new information and modify the QCP when needed Quality Control Plan How do we prevent or detect failure http www cms gov Regulations and Guidance Legislation CLIA Downloads IQCP Workbook pdf Data sourced from pg 43 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED Let s do a practice IQCP Risk Assessment FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 38 fr m Things to consider if you want to do an IQCP on the Acme Company Lab Test If Acme Company s Test recommends QC frequency less than CLIA you have to perform 2 levels of external QC each day of testing OR perform an IQCP Look at your Acme Company Test if the QC protocols would be costly running external controls daily then PRIORITIZE the development of an IQCP r Example of a Risk Analysis Worksheet from Alere Alere Triage System Labeling Instructions Warnings and Precautions All specific information he
4. assigned est volume may drive requency needed for Field Surveyor The Joint Commission Stacy Olea MBA MT ASCP FACHE Executive Director Laboratory Accreditation The Joint Commission AACC July 2015 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 47 Let s do a practice Quality Control Plan FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED Anywhere Medical Center Laboratory Acme Company Test Example QCP Worksheet These examples are not meant to be all inclusive of all possible QC procedures that may apply to your laboratory Laboratory Anywhere Medical Center Acme Company test Location NICU Procedural Control With each patient Must be documented as acceptable according to package insert on the quality control log sheet prior to specimen reporting results emperature Checks List all range as specified in the package insert for room refrigerator and freezer These ranges will be recorded on the temperature log sheets Refer to Specimen Rejection Policy and record all improperly collected tubes on specimen rejection log sheet Acceptable external control values are within laboratory determined ranges Results must be recorded on quality abnormal quality control log sheet prior to reporting results control no less than package insert for additional conditions to be run Reagent Device Storage With each reagent Document date and time on reagent device when removed from the refrigerator Foll
5. AL USE PRINT AND DISTRIBUTION ARE PERMITTED 42 wad RA Acme Company Test Environment Laboratory Anywhere Medical Center Test System Acme Company est Location NICU Preanalytic and Temperature of testing area humidity and or Monitoring and Ititude out of range documentation of emperature and humidity competency and P amp P esting area not free of vibration and or not level Appropriate test area designation Designated area not free of contamination NICU YES Appropriate test area in a dirty utility room designation and site audits Data sourced from Developing a Successful IQCP Let s Keep it Simple Slide 64 Elia Mears MHA MT ASCP SM Field Surveyor The Joint Commission Stacy Olea MBA MT ASCP FACHE Executive Director Laboratory Accreditation The Joint Commission AACC July 2015 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 43 est Location NICU Preanalytic and Reagent degradation if improper temperature pon receipt If test device has a changed exp date new exp date not labelled on test device est device not used immediately after out of pouch Data sourced from Developing a Successful IQCP Let s Keep it Simple Slide 63 Elia Mears MHA MT ASCP SM p RA Acme Company Test Reagent Laboratory Anywhere Medical Center Test System Acme Company Record conditions on eceipt document emperatures room emperature storage documentation and If test devices out of box exp
6. al Technical Bulletin Quality controls will detect General Test Device Failure error code one lraagent Control Features 10001645 TE 0107 13 failures Reagent p Step by Step Risk Analysis Assessment ppeomen S A S ewe Fragen fes Syse a S S fesing Persen S a S Data sourced from Developing a Successful IQCP Let s Keep it Simple Slide 36 Elia Mears MHA MT ASCP SM Field Surveyor The Joint Commission Stacy Olea MBA MT ASCP FACHE Executive Director Laboratory Accreditation The Joint Commission AACC July 2015 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 41 p RA Acme Laboratory Anywhere Med est Location NICU i Preanalytic rong sample type incorrect anticoagulant inadequate fill of tube patient misidentification and specimen labelling errors Bubbles or air in sample Improper lancet and capillary collection plain plastic Li Heparin clots and inadequate mixing Data sourced from Developing a Successful IQCP Let s Keep it Simple Slide 61 Elia Mears MHA MT ASCP SM raining and ompetency on ollection technique ollow manufacturer s instructions for specimen requirements Policy and Procedures P amp P raining and ompetency on ollection technique removal of air Direct observation and P amp P Field Surveyor The Joint Commission Stacy Olea MBA MT ASCP FACHE Executive Director Laboratory Accreditation The Joint Commission AACC July 2015 FOR EXTERN
7. ality l l Assessment Assessment e List of errors and actions to mitigate the risks Quality Assessment e Monitoring of that plan FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 18 Component 1 Risk Assessment FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 19 p Collect Necessary Documents Package Insert Regulatory 7 Requirements FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 20 r A Simple Approach to Risk Assessments ASK What controls do I have in place Map out How likely the test is it to process happen FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 21 p Map Your Testing Processes l Test R t ce mg Yes Assemble test components Run test Bring all Investigate components Enter patient to room temp information oeiee NO Collect sample valid FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 22 1 2 Samples Operator Sample Integrity Atmospheric Environment Lipemia Operator Capacity gt i Dust Hemolysis Training Temperature Interfering substances Competency Humidity 7 Clotting Incorrect tube Sample Presentation Operator staffing gt Utility Environment Bubbles Short staffing Electrical Inadequate volume Correct staffing Water Quality z Pressure Identify Potential Hazards Reagent Degradation Shipping Storage Used past expiration Prepa
8. ay be required by local state or other accrediting groups Analysis of identical devices used in various locations Review of the Quality Control Plan elements Routine e Failure investigations e CAPA including return to the Risk Assessment Annual review of the Quality Control Plan FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED p 62 Pages Worth Reading INDIVIDUALIZED QUALITY CONTROL PLAN DEVELOPING AN IQCP STEP BY STEP GUIDE http www cms gov Regulations and Guidance Legislation CLIA Downloads IQCP W orkbook pdf FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED CLIA Laboratory Director Responsibilities Accurate and reliable test results that are appropriate for patient care no matter what QC method they use Quality Control Plan Data sourced from Developing a Successful IQCP Let s Keep it Simple Slide 15 Elia Mears MHA MT ASCP SM Field Surveyor The Joint Commission Stacy Olea MBA MT ASCP FACHE Executive Director Laboratory Accreditation The Joint Commission AACC July 2015 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED p What We re Hearing from Joint Commission Delegate in writing to qualified personnel the development and implementation of the QCPs Review sign and date the QCPs before patient testing begins and results are reported This cannot be delegated Required forms COM 50200 Only tests that employ an inte
9. e action logs Personnel competency Instrument maintenance logs Data sourced from CAP All Common Checklist July 28 2015 Permission granted by College of American Pathologists FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 13 p What We re Hearing from COLA Individualized Quality Control Plan IQCP Permission to Use Copyrighted Material granted by COLA Resources Inc CRI a laboratory medicine educational and GP QCmadeEZ consulting organization located at 9881 Broken Land Parkway Suite 215 IMPLEMENTATION GUIDE Columbia Maryland 21046 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 14 pA For More Information qualitylabs jointcommission org Go to the Leading Practice Library IQCPQalere com www alere com IQCE Joint Commission FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 15 Pen to paper suggestions What you can do right away FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED Mac Create the Team The Laboratory Director may delegate responsibility in writing to eee a Technical Consultant or Director Technical Supervisor Laboratory Director is ultimately responsible for the plan its design its approval and compliance Phlebotomy AVAVA FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED Maa Parts of an IQCP Risk Assessment e Process to identify risks Quality Control Plan Quality Control Plan Risk Qu
10. e and RALS are trademarks of the Alere group of companies SAHIGHR 0067 A FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED
11. iration changes new date on test device and ew expiration date on RT stored cart P amp P training and ompetency Field Surveyor The Joint Commission Stacy Olea MBA MT ASCP FACHE Executive Director Laboratory Accreditation The Joint Commission AACC July 2015 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 44 Example of Cut and Paste IQCP Support Document Laboratory Anywhere Medical Center Test System Acme Company est Location NICU Preanalytic and Reagent degradation if improper temperature upon receipt Record conditions on receipt document emperatures room emperature storage documentation and monitor storage areas If test devices out of box expiration changes new date on test device and new expiration date on RT stored cart If test device has a changed exp date new exp date not labelled on test device pouch ompetency Reagents must be Stored according to the Pl and UM Expiration date is based on reagent stability studies echnical Bulletin Quality Control Features 10001645 01 07 13 Preanalytic Outdated test device use of expired devices beyond 14 day room temperature storage est device not used immediately after out of mm training and Data sourced from Developing a Successful IQCP Let s Keep it Simple Slide 63 Elia Mears MHA MT ASCP SM Field Surveyor The Joint Commission Stacy Olea MBA MT ASCP FACHE Executive Director Laboratory Accreditation The Joint Commissi
12. ite inspection Laboratory Laboratory Name Section Department 3 Number EE Date of 1 Instrument Device 2 Tests 4 List of Test Sites Date Date Include name List all tests included of Devices If used in more than one Director manufacturer and model under the IQCP area Implemented Retired In Use Approval Click here to Click here to Click here to enter a date enter a date enter a date 5 Process Used to Monitor Risk List control processes put in place based on risk assessment define the monitor and frequency evaluated Reagents Environment Specimen Test System Testing Personnel Other The form is intended to be used for developing an IQCP or the performance for a risk assessment The form is to be completed by laboratories preparing for a CAP inspection Inspectors will use this form and IQCP List as tools for audit the IQCPs in use during a CAP onsite inspection Permission granted to use this form by College of American Pathologists WW COM 50600 Quality Assessment Monitoring to include the following Reagents Ongoing assessments may include but are not Specimen limited to the review of the following records Environment Test system Testing personnel Quality control Proficiency testing Patient results review Specimen rejection logs Turn around time reports Error correctiv
13. on AACC July 2015 Ww RA Acme Company Test Test System Laboratory Anywhere Medical Center Test System est Location NICU est System Preanalytic and Wrong User ID raining and Postanalytic ompetency P amp P and verification of results before reporting or adding a data manager system such as RALS as an Manual Reporting error Procedural control and external controls what to YES Understand how do if fails procedural control orks QC failures P amp P and follow manufacturer s instructions Data sourced from Developing a Successful IQCP Let s Keep it Simple Slide 62 Elia Mears MHA MT ASCP SM Field Surveyor The Joint Commission Stacy Olea MBA MT ASCP FACHE Executive Director Laboratory Accreditation The Joint Commission AACC July 2015 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 46 Laboratory Anywhere Medical Center Testing Personnel est Location NICU Operator training PRN s trained How frequent do PRN s perform the test esting personnel and qualifications inadequate Short staffed or license requirements not verified Low test volume and inadequate testing experience Data sourced from Developing a Successful IQCP Let s Keep it Simple Slide 65 Elia Mears MHA MT ASCP SM wa RA Acme Company Test Testing Personnel ompetency and raining of all personnel required P amp P Documentation of education and qualifications at the time of hire or when responsibility
14. ow package insert device instructions for handling reagents raining With each new Successful demonstration of test performance Document training activities esting personnel land when indicated Competency Assessment Six months and All testing personnel must successfully meet all six CLIA elements for competency assessment one year after initial raining annually hereafter Laboratory Director Approval and Signature Laboratory Director or Designee Review and Signature http www cms gov Regulations and Guidance Legislation CLIA Downloads IQCP Workbook pdf pg 37 38 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 49 Anywhere Medical Center Laboratory p Acme Company Test Example QA Worksheet Laboratory Anywhere Medical Center Acme Company test Location NICU Remedial training of testing Review all temperature logs Monthly es personnel Reassess testing personnel performance Remedial training of processing Review all specimen Monthly personnel Reassess processing rejection logs personnel performance EE ReviewQClogs NoN e e II Alerts As Needed As needed Review training logs based on Staffing As needed Review personnel haa based on new qualifications Pree Review competency Annually assessments Data sourced from Developing a Successful IQCP Let s Keep it Simple Slide 68 Elia Mears MHA MT ASCP SM Field Surveyor The Joint Commission Stacy Olea MBA MT ASCP FACHE Executive Di
15. ration E Shipping Quality Control Material Degradation Storage Shipping Used past expiration Storage z Preparation Used past expiration Preparation 3 Reagents p Map Your Testing Process 4 Laboratory Environment Calibrator Degradation 5 Measuring System Permission granted from Laboratory Quality Control Based on Risk Management Approved Guideline CLSI document EP23 A pg 22 Wayne PA Clinical and Laboratory Standards Institute 2011 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED Incorrect Test Result Instrument Failure Software failure Optics drift Electronic Instability Inadequate Instrument Maintenance Dirty optics Contamination Scratches 23 kd Categorize the Process Steps FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED kd Collect Data and Provide a Data Summary Historical Data Evaluate om Collect sig Impact y O u r data pt Where the Failures Occurred Frequency of Failures FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 25 Things to Include in Historical Quality Summary Statistics Internal external QC review Corrected reports and physician complaints FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 26 Negligible e Inconvenience or temporary discomfort Minor e Temporary injury or impairment not requiring professional medical inter
16. re is taken from the Alere Triage User Manual revision B Alere Triage BNP Product Insert PN 26159en Rev C Alere Triage Cardiac HS Product Insert PN 26161en Rev D Alere Triage D Dimer Product Insert PN 26164en Rev D and Alere Triage TOX Drug Screen Product Insert PN 26171en Rev A Alere Triage goe System Risk Laboratory Documentation Laboratory Risk Mitigation Cause Failure Type Effect s of Mitigation Failure Severity Frequency Features Guided Not following Testin instructions Package Insert PI Operator failure manufacturer 9 are on the and Instrument User i Personnel instructions screen of the Manual UM instrument Alere shipping containers Improper r n li ntrol an Test Device properreage i designed to Qua ty Control a d s shipping Environment Warnings and Precautions Handling appropriately temperature sections of PI control temperature Outdated test Expiration date gt Warnings and Precautions of g embedded in the See ER device use of Testing Personnel PI Expiration dating is p i device barcode that expired devices f printed on every test device is read by meter Outdsteditece Reagents must be stored deviceuse of according to the PI and UM Expiration date is based expired devices ae berede Reagent None on reagent stability Be Se studies Technical Bulletin pa 3 Quality Control Features 8 10001645 01 07 13 Test Device ee Failure ullt in Procedur
17. rector Laboratory Accreditation The Joint Commission AACC July 2015 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 50 p Draft an IQCP Standard Operating Procedure E I nr E An IQCP SOP is not required by CMS but should be considered as good laboratory practice and may be required by local state or other accrediting groups IQCP Helpful Hints FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 52 r Tips E An IQCP links potential failures to QC procedures e If a QC procedure doesn t link to an IQCP failure STOP DOING IT Multiple tests on a cartridge Devices in multiple locations The manufacturer RA spreadsheets could be a starting point e Feel free to modify them to work for you e Don t forget about the pre and post analytical failures IQCP SOP may be incorporated into existing QCP and QA SOPs Best guide Developing an IQCP A Step by Step Guide In Closing Your biggest obstacle Finding time to work on your IQCP Delegate tasks to staff Don t reinvent the wheel Select an example template and start You can get some things completed on your IQCP tomorrow Don t stress over making your IQCP perfect Keep it Simple If you haven t started yet get started tomorrow FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED Thank You Questions 2015 Alere All rights reserved The Alere Logo Alere Knowing now matters Triag
18. rnal quality control system electronic procedural or built in control qualify More stringent QC than CMS p What We re Hearing from CAP Individualized Quality List of Individualized Control Plan Quality Control Plans Summary Exception Microbiology media and reagents used for microbial identification and susceptibility testing CAP requires external QC every 31 days Data sourced from CAP All Common Checklist July 28 2015 Permission granted by College of American Pathologists FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED ww COM 50400 and COM 50500 Quality Control Plan d A Contain criteria to determine acceptable QC results Specify the number type and frequency of testing QC material s Provide for immediate detection of errors for each phase of the CAP accreditation Must meet regulatory and requirements testing process Follow manufacturer s instructions and recommendations for QC at minimum Indicate that your laboratory director reviewed signed and dated the QCP document Data sourced from CAP All Common Checklist July 28 2015 Permission granted by College of American Pathologists FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED COLLEGE of AMERICAN PATHOLOGISTS Individualized Quality Control Plan Summary Complete a separate form for each IQCP in use and present to the inspector during the on s
19. vention Serious e Injury or impairment requiring professional medical intervention e Permanent impairment or life threatening injury Catastrophic e Results in patient death Permission granted from Laboratory Quality Control Based on Risk Management Approved Guideline CLSI document EP23 A pgs 25 26 Wayne PA Clinical and Laboratory Standards Institute 2011 aiid Ranking Severity of Failure and Probability of Harm Frequent e Once per week Probable e Once per month Occasional e Once per year Remote e Once every few years Improbable e Once in the life of the test system HNI FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 27 p Risk Acceptability Matrix severity of Harm of harm Frequent Probable OK OK Occasional Remote Improbable Permission granted from Laboratory Quality Control Based on Risk Management Approved Guideline CLSI document EP23 A pg 27 Wayne PA Clinical and Laboratory Standards Institute 2011 FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED 29 r Quality Control Plan Nothing less than the manufacturer s recommendations or local state or AO requirements Lab Director approval sign and date FOR EXTERNAL USE PRINT AND DISTRIBUTION ARE PERMITTED r Quality Control Plan Identify the processes that need additional controls

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