Laboratory Quality Assurance

 

Survey Checklist Information

To assist testing sites in preparing for an on-site inspection, materials are available from LQA, upon request or through the supplemental material and forms links.

On-site Survey Process

Routine on-site surveys are typically announced, with the date and time established between the laboratory surveyor and the testing site staff.

Upon arrival at the testing site, the surveyor meets with the laboratory director and other pertinent technical staff to explain the survey process and the records necessary for review. During a walk-through of the specimen collection and testing areas, the surveyor notes issues related to space, equipment, utilities, reagents and testing materials, cleanliness and safety.

To assist testing sites in preparing for an on-site inspection, the following materials are available from LQA, upon request or through the links below:

  • Technical procedures, quality control/quality assurance policies, safety manual
  • Personnel records (qualifications, training checklists, competency assessment documentation)
  • For the previous two years:
    • Patient test requisitions (or other format used to document test orders, such as charts)
    • Accession logs
    • Test result logs, worksheets
    • Instrument printouts, tapes
    • Records of quality control, calibration, equipment function checks and maintenance records, temperature records, etc.
    • Documentation of quality assurance activities, problem resolution
    • Proficiency testing results and corrective action documentation as indicated
    • Patient test reports (or other format used to document test results, such as charts)

During the course of the survey, the surveyor points out any deficiencies as they are found and gives the staff an opportunity to clarify any misunderstanding or to provide records or documentation as needed. At the completion of the survey, the findings are shared with the director and staff. Technical assistance is provided throughout the survey and during the exit conference to help the MTS in developing a plan of action to correct their deficiencies.

If no deficiencies are found, a letter, stating that the laboratory is in compliance, is mailed within 10 days to the director.

If deficiencies are cited, a deficiency statement is mailed within 10 days to the director. The MTS must return a written plan of correction for each deficiency within 14 days of the postmark of the letter stating the deficiencies. Corrections must be made no later than 60 days following the department's approval of the plan of correction. The surveyor will contact the facility requesting documentation that the correction of the deficiencies is complete and effective. When all deficiencies have been corrected, a letter, stating the laboratory is in compliance, is sent to the director.