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SECTION II: THE ROAD TO ACCREDITATION>Documents Necessary for the On-site SurveyThe surveyor will need the documentation described below, including patient charts when requested, for a two-year periodprior to the survey, or from the date of the last COLA survey or other CLIA inspection.These records should be collected just prior to the survey and placed in a room with an electrical outlet. The list below isnot all-inclusive, but represents the basic items required. Depending on individual circumstances, the surveyor may requestadditional records.Please have the following available:Copy of current CLIA Certificate for surveyor to review and keep if requiredCopy of current Test Volume calculations for surveyor to verifyPersonnel files for each laboratory employee (including physicians) performing non-waived testingPersonnel files must include:1. Proof of education according to CLIA ‘88 requirements. The following documents are acceptable:High school diploma or GEDTranscripts (must have date graduated)College degrees (AA, BS, MS, PhD)Professional license (e.g. RN, NP, PA, or MD/DO license)> NOTE: Medical Assistants and LPNs must have either high school or AA diplomas available.Those employees with only foreign educational documents must have them evaluated for U.S.equivalency.2. Written performance evaluations and competency assessments. New employees must be evaluated at sixmonths and also one year after their hire; other employees must be evaluated yearly3. Records listing laboratory-related continuing education and annual OSHA/Bloodborne Pathogens training4. Training documents for all new employees5. Current job descriptions for all laboratory positionsPolicy and Procedure Manual(s)Current package inserts for all kit tests and reagents (including all waived methods), controls, and calibration materialsused during the survey periodProficiency testing (PT) records including instrument tapes, PT submission form, attestation statements, gradedresults, and corrective actions taken for all unsatisfactory scores, and evidence of self-evaluation of any ungradedresultsCalibration, maintenance, and function check records for current and discontinued instruments used during thesurvey periodTemperature and humidity recordsAll quality control (QC) records, graphical representations, charts, and any other documentary logsTest requisitions and report forms used for all laboratory testing. The surveyor may ask to review several patient chartsQuality Assessment (QA) Plan and documentation of implementation, with QA reviewsIncident Management Plan and any reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org2-9