The following materials are generally required to be available to the surveyors at some point during the laboratory survey:
- All CLIA certificates
- Completed test volume and specialty report (see page 26)
- Administrative policies and procedures
- Technical procedure manuals for all areas
- Specimen collection procedure manuals
- Quality control policies and procedures
- Safety and infection control procedures (including the chemical hygiene plan)
- Evidence of medical direction or consultation (as applicable)
- Transfusion services policies and procedures
- If applicable, policies and procedures governing cell savers
Tissue storage policies and procedures (bone, tendons, skin, other tissue)
- Documentation related to blood warmers
- Records for tests done outside of main laboratory, when applicable
- Track records of performance improvement or quality assessment and improvement activities
- Departmental records for inpatients (if applicable) and outpatients
Staffing information
- Applicable laboratory and personnel licenses
- Job descriptions and performance appraisals, including annual competency assessment
- Personnel information showing qualifications
- Education programs and records of participation
- Evidence of director input in education programs
- Education program details and school agreements, as applicable
- Preventive maintenance reports for all equipment
- Instrument function, calibration, maintenance, and repair records
- Temperature records for all temperature compensated spaces
- Contracts for services (if applicable)
Documents that evidence a twelve-month track record for the following:
- Quality Control activities from all aspects of laboratory services provided
- Evidence of corrective action taken in quality control
- Method validation, calibration, and calibration
verification records as needed
Documents that evidence a twenty-four-month track record for the following:
- Proficiency testing data for each specialty and subspecialty, including corrective action, evidence of annual enrollment attestation statements, instrument tapes or testing records.