#06-5558 Accrd Manual V7 - COLA

CRITERIA FOR QUALITY LABORATORY PERFORMANCEORG 7 RDo you have systems in place to maintain the confidentiality of patient information throughout all phases of thetesting process?Confidentiality of patient information, including patient charts and reports, must be protected throughoutpre-analytical, analytical and post-analytical phases of the testing process in accordance with federal andstate laws. This includes patient charts as they follow the patient throughout an office visit. This mustaddress electronic and/or hardcopy results (as applicable).ORG 8 RDoes the laboratory maintain a posted notice to employees, advising them how to report concerns related tothe safety and quality of patient testing as performed in this facility?Complaints regarding laboratory services may be recognized and brought forward by internal customers(such as employees) or external customers (such as patients, or referring clinicians). This criterion focuseson the communications to employees regarding the protocol for reporting concerns that could impact thesafety or quality of patient testing. This should be addressed in your Quality Assessment Program so that aninvestigation can be conducted, and corrective actions taken as necessary.As your accrediting agency COLA takes complaints made against an accredited laboratory seriously. Yournotice should encourage staff to use internal protocols to report potential safety or quality issues pertainingto patient testing. It should also inform employees that the issue may be reported to COLA, if it is notaddressed or cannot be resolved through internal channels.COLA has created a notice that accredited labs can post to meet this requirement. It can be obtained bydownloading the notice from the COLA website (www.cola.org). The notice should be posted in a conspicuousplace, where it can be easily seen by employees.ORG 9 RDoes the laboratory have a procedure for the FDA voluntary reporting of device-related adverse events?Every laboratory should have a procedure for voluntary reporting device-related adverse events to the FDA.Device-related adverse events cause serious patient injuries that are life threatening; or result in permanentimpairment of a body function or permanent damage to a body structure; or necessitate medical or surgicalintervention to preclude permanent impairment of a body function or permanent damage to a body structure.Inaccurate test results produced by an In vitro device (IVD) and reported to the health care professionalmay lead to medical situations that fall under the definition of serious injury as described above, andtherefore are reportable events.Device malfunctions or problems that are reportable may relate to any aspect of a test, including hardware,labeling, reagents or calibration; or to user error (since the latter may be related to faulty instrument instructionsor design).For additional information, please visit COLA’s website (www.cola.org).ORG 10 RDoes the laboratory have documented education of its personnel in the FDA procedure for voluntary reportingof device-related injuries and/or malfunctions?Laboratory documents training of staff on the FDA voluntary reporting procedures.ORG 11 EDo you have a procedure manual?Every laboratory should have a complete procedure manual that includes test procedures as well as generallaboratory policies. For further help with how to write a procedure, see COLA LabGuide 1–“Contents of aProcedure Manual.”2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org