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SECTION II: THE ROAD TO ACCREDITATIONIMPORTANT:Know COLA’sStandards forPerformanceThe COLA standards are shown in detailin Section III of this Manual – Criteriafor Quality Laboratory Performance. Thefollowing are evaluated by COLA todetermine if a laboratory meets COLAstandards:• Organization• Facility• Personnel• Proficiency Testing• Laboratory Information Systems• Pre-analytic Activities• Procedure Manual• Maintenance• Verification of PerformanceSpecifications• Calibration• Quality Control• Specialty Specific Criteria• Post-analytic Activities• Quality AssessmentThere are separate sets of additionalcriteria for laboratories that perform:• Immunohematology/Transfusion Services• Cytology• HistopathologyParticipate in Proficiency TestingWhile COLA is not a proficiency testing provider, we do monitor yourfacility’s proficiency testing performance as part of the accreditationprocess and offer guidance to help you achieve successful results.Assistance is Just a Phone Call or E-Mail AwayAs laboratories work toward compliance, COLA encouragesparticipants to contact our Call Center at (800) 981-9883. Speakwith our technical staff who are capable of answering questionsabout instrumentation, record-keeping, quality assessment, and ahost of other topics.Confidentiality Provisions ApplyCOLA will not release any information identifying an individuallaboratory unless the release of this information is required by lawor is authorized by the director of the laboratory. COLA will releaseto participant laboratories copies of their accreditation informationsubmitted to the COLA office, provided that the laboratory directorrequests the information in writing.COLA complies with requirements of the Health InsurancePortability and Accountability Act (HIPAA) and takes appropriatemeasures to safeguard and protect the confidentiality of anyprotected health information which it may receive as a result of itsaccreditation survey and documentation review.Under HIPAA, COLA is a business associate to laboratories that itaccredits. COLA has a model agreement that labs may use if they donot have their own business associate agreement.COLA reserves the right to copyright and publish aggregate dataobtained from participating laboratories and from the proficiencytesting programs to which these laboratories subscribe. COLA maylicense others to copy and otherwise use such aggregate data.Aggregate data or other information not identifying individual labsmay be released by COLA to other entities such as memberorganizations, the government, or individuals or organizationsdeemed to have a legitimate need for the data.Laboratories accredited by COLA under a deeming relationshipwith another accrediting organization must agree to authorizeCOLA to release its findings to the primary accrediting organization.2-4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
SECTION II: THE ROAD TO ACCREDITATION>Your Responsibilities in the Accreditation ProcessYour organization, with the assistance of COLA, will be responsible for taking leadership for the followingactions during the laboratory accreditation process.Your laboratory will…• Carefully review this Accreditation Manual and complete the forms and promptly respond to other informationrequests from COLA• Meet other regulatory notification and procedural requirements as stipulated by federal and state agencies• Develop a comprehensive action plan for performing the Self-Assessment, involving staff members• Assess and ensure compliance with qualifications and responsibilities of the laboratory director and eachCLIA-required laboratory position• Educate and train personnel to ensure skill and competency requirements are met for quality laboratoryperformance• Take timely corrective action for identified noncompliancesCompleting Accreditation: Checklist for ActionAccreditation is granted to a laboratory once it meets all COLAstandards and criteria, and completes the following actions (checkoff each item as you complete it):Pays all feesMeets personnel requirementsMeets applicable state laboratory requirementsEnrolls in an approved proficiency testing programContinues to be successful in proficiency testingReturns all laboratory information formsNotifies COLA of changes in its personnel, test menu, orinstrumentationIMPORTANT:Meet Deadlines & TakeRequired ActionSome information requests and correctiveaction responsibilities require timelyaction by laboratory staff. Make sureyou adhere to the requirements withinthe various stages leading towardaccreditation.Also, look for material throughoutthis Manual that outlines importantinformation about responsibilities thelaboratory must fulfill and actions itmust take during accreditation.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org2-5
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