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Documents to be Available at the Time of Survey

Joint Commission on Accreditation of Healthcare Organizations


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.

 

 

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