Download - COLA

More documents

Recommendations

Info

SECTION III: COLA CRITERIA FOR QUALITY LABORATORY PERFORMANCECA 2 RIs calibration verification performed, according to the manufacturer’s instructions including:• the number, type and concentration of materials to be used,• use of materials at low, medium and high values within the reportable range, as determined by the laboratory,• acceptable limits for calibration verification, once every six months or more often if required by laboratoryprocedures?Calibration verification is intended to confirm that the calibration setting continues to provide accurate results overthe reportable range of the test system. It requires a minimum of three (3) specimens, (low, mid-point, and high). Thesespecimens need to have known values and should be tested in the same manner as patients. The results obtained arethen compared to the known values within manufacturer or laboratory defined limits of acceptability. If the calibrationis holding, the recovered value should match the expected value. If not, recalibration is indicated.This procedure is used to verify that a new lot of reagents, a complete change of reagents, or instrument service ofcritical parts has not negatively affected the calibration. It may also be used in troubleshooting unacceptable QCresults.If the laboratory’s calibration procedures includes 3 or more standards (low, mid point, and high) and is performed atleast every 6 months, the requirement for calibration verification is automatically met and the laboratory does notneed to take further action in this regard.EXCEPTIONS• For automated cell counters, calibration verification is met if the lab follows manufacturer’s instruction for instrumentoperation and performs a minimum of two (2) levels of QC each day of testing.• For test systems which the laboratory performs three (3) levels of NIST traceable controls (low, mid, and high range)more than once each day of testing and follows manufacturer’s instructions, the requirement for calibration verificationis met.CA 3 RDo you follow accepted methods for calibration and calibration verification for all non-waived test systems?These instructions can be found in your instrument operator’s manual.CA 4 RDoes the calibration procedure use calibration materials that are traceable to a National Institute of Standardsand Technology (NIST) standard?Most standards which are usually included with the reagents for the test is traceable to a NIST standard, or othernational or worldwide standard. Refer to the package insert included with the reagents. If the package insert does notindicate this, check with your manufacturer. Traceable standards are not available for all analytes. You may need topurchase a separate standard set, traceable to a NIST standard, to be used only for calibration or calibration verification.3-50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
SECTION III: COLA CRITERIA FOR QUALITY LABORATORY PERFORMANCE>CA 5 RDo you perform calibration verification whenever a new lot number or a complete change of reagents occurs,unless it can be shown that such changes do not affect test results?Exception: Calibration verification does not need to be performed in the case of a lot number change or a completechange of reagents if it can be shown that the calibration of the instrument or method is not affected by thesechanges. This can be demonstrated by documenting several consecutive instances where there were no adjustmentsto the calibration needed.CA 6 EDo you perform a calibration verification whenever a test system has major preventive maintenance; a critical partis changed; and when controls show shifts, trends, or are out-of-limits; and recalibrate whenever the instrument failscalibration verification?Service contracts include calibration as part of the preventive maintenance performed by the contractor. If they performthis necessary calibration for you, be sure to retain all relevant documentation.CA 7 RDoes the laboratory perform and document all corrective actions taken when calibration/calibration verificationvalues are not within established limits?CA 8 RDo you recalibrate when quality control shows trends, shifts, or is out of limits, and other corrective action hasnot remedied the problem?This is a good troubleshooting and corrective action step to be taken after other corrective actions have been attemptedand failed to rectify the problem. Sometimes calibration drifts on instruments between regularly scheduled calibrationsand needs to be re-set. Many times recalibration corrects the Quality Control problem. If this doesn’t work, it maybe time to request a service call for the instrument.CA 9 RDo you keep records of all calibration and calibration verification activities including the number, type andconcentration of materials used, results obtained, and any adjustments to the calibration?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org3-51
Page 1 and 2:
COLA LABORATORYACCREDITATION MANUAL
Page 3 and 4:
TABLE OF CONTENTS>I Introduction to
Page 5 and 6:
SECTION I: INTRODUCTION TO ACCREDIT
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
SECTION II: THE ROAD TO ACCREDITATI
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31 and 32:
Page 33 and 34: SECTION II: THE ROAD TO ACCREDITATI
Page 35 and 36: SECTION III: COLA CRITERIA FOR QUAL
Page 83: SECTION III: COLA CRITERIA FOR QUAL
Page 129 and 130: SECTION III: IMMUNOHEMATOLOGY AND T
Page 135 and 136:
SECTION III: IMMUNOHEMATOLOGY AND T
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
SECTION III: CYTOLOGY>CYTOLOGYIntro
Page 147 and 148:
SECTION III: CYTOLOGY>710. EIs ther
Page 149 and 150:
SECTION III: CYTOLOGY>721. EAre the
Page 151 and 152:
SECTION III: CYTOLOGY>Examination P
Page 153 and 154:
SECTION III: CYTOLOGY>748. EReevalu
Page 155 and 156:
SECTION III: CYTOLOGY>761. EA compa
Page 157 and 158:
SECTION III: CYTOLOGY>Specific CLIA
Page 159 and 160:
SECTION III: CYTOLOGY>797. EDoes th
Page 161 and 162:
SECTION III: HISTOPATHOLOGY>HISTOPA
Page 163 and 164:
SECTION III: HISTOPATHOLOGY>Personn
Page 165 and 166:
SECTION III: HISTOPATHOLOGY>833. ED
Page 167 and 168:
SECTION III: HISTOPATHOLOGY>The lab
Page 169 and 170:
SECTION III: HISTOPATHOLOGY>858. EA
Page 171 and 172:
SECTION III: HISTOPATHOLOGY>870. EW
Page 173 and 174:
SECTION III: HISTOPATHOLOGY>886. EI
Page 175 and 176:
SECTION IV: EDUCATIONAL RESOURCES &
Page 177 and 178:
SECTION IV: EDUCATIONAL RESOURCES &
Page 179 and 180:
SECTION V: APPENDIX>IN THIS SECTION
Page 181 and 182:
SECTION V: APPENDIX>CAP Excel/Surve
Page 183 and 184:
SECTION V: APPENDIX>DIRECTOR1. Lice
Page 185 and 186:
SECTION V: APPENDIX>A B C DProductM
Page 187 and 188:
Page 189 and 190:
Page 191 and 192:
Page 193 and 194:
Page 195 and 196:
Page 197 and 198:
Page 199 and 200:
SECTION V: APPENDIX>(a) General. Th
show all

Download - COLA

Create successful ePaper yourself

Delete template?

Save as template?