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. The following records should be available for review:
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.
