#06-5558 Accrd Manual V7 - COLA

CRITERIA FOR QUALITY LABORATORY PERFORMANCEAnalytic - General RequirementsProcedure ManualDoes the procedure manual include for each test, where applicable: (APM 1-19)APM 1 RThe test name?APM 2 (PRE) RDirections for patient preparation; specimen collection preservation, storage and handling?These may be included in a separate section (or manual) on specimen collection.APM 3 (PRE) RWritten instructions for the collection and storage of specimens that a patient would collect themselves?APM 4 (PRE) RCriteria for specimen acceptability and rejection of unacceptable specimen?APM 5 (PRE) RInstructions for patient and physician notification if a specimen is unacceptable?When a specimen is unacceptable, the laboratory should document the reason it is unacceptable, whethertesting could still be performed but results may be compromised or whether the specimen could not be usedand who was notified of the problem.In some laboratories the patient may be waiting and can easily be re-collected and testing can be performed.In other circumstances it may be impossible to re-collect the specimen. The clinician should be notified sothat proper patient follow-up can be assured.The laboratory will want to monitor the frequency and reason for unacceptable specimens as part of theirquality assessment activities. It may be possible to recognize patterns associated with unacceptable specimensthat lead to identification of problems that could affect the quality of laboratory results.APM 6 RDirections for preparing and storing reagents, solutions, stains, standards and controls?The directions for preparation should describe the concentration, strength and titer (where applicable) of areagent, standard, or control. The directions should instruct the individual to ensure all reagents, solutions,stains, standards and controls are properly labeled as to content, date of preparation and expiration. (SeeMA 1).APM 7 RDirections for calibration or standardization, calibration verification and corrective action for failures?Directions for calibration and calibration verification procedures should include the following:• Identification of the type and concentration of materials to be used,• The number of calibrators required,• Step by step instructions for performing the calibration or calibration verification procedure• Acceptable limits or criteria for interpretation of results• Corrective actions to be taken if the calibration or calibration verification is unacceptable.APM 8 RControl procedures and criteria defining unacceptable control results?18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org