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SECTION III: 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, whether testingcould still be performed but results may be compromised or whether the specimen could not be used and who wasnotified of the problem.In some laboratories the patient may be waiting and can easily be re-collected and testing can be performed. In othercircumstances it may be impossible to re-collect the specimen. The clinician should be notified so that proper patientfollow-up can be assured.The laboratory will want to monitor the frequency and reason for unacceptable specimens as part of their qualityassessment activities. It may be possible to recognize patterns associated with unacceptable specimens that lead toidentification 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 a reagent,standard, or control. The directions should instruct the individual to ensure all reagents, solutions, stains, standardsand controls are properly labeled as to content, date of preparation and expiration. (See MA 1).3-38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org