Maintaining a Comprehensive Quality Control Program


Maintaining a Comprehensive Quality Control Program

Page 6

inspection insights

Maintaining a Comprehensive Quality Control Program

Cathy J. Carver, MT(ASCP)

Most of us are familiar with quality control (QC) requirements for individual test systems, but CLIA has a broader focus when examining QC. Your surveyors will most likely be looking at a bigger picture, including QC, calibration, in-house policies and procedures, and manufacturer’s instructions. I like to separate my QC policies into two categories: general laboratory QC program and test system QC.

CATHY CARVER General Laboratory QC Program

Each laboratory should maintain a QC program to ensure accuracy of results reported. It should include written protocol for: 1) following the manufacturer’s written instructions for instrument or test system operations and performance; 2) having and using a procedure manual; 3) performing calibration; 4) performing control procedures; 5) performing corrective actions when systems are “out of control”; 6) verification of quantitative methods; and 7) documentation of all these activities.

Consider the following examples:

Following the Manufacturer’s Instructions. This includes performing instrument maintenance, using approved reagents and controls (for moderate complexity testing), following environmental requirements, storage requirements for reagents or other supplies, and calibration procedures.

Procedure Manual. A written procedure manual containing procedures for all lab activities must be maintained and available, and it must be approved by the lab director when first implemented with notation of approval by signature and date. The lab director will review the manual annually, and any new lab director will review the manual within 30 days. If a procedure requires a change, a new procedure will be written, approved and inserted into the manual. The old procedure will be retained for two years. New personnel will read the entire manual as part of orientation, with documentation of review in personnel records.

Calibration. The recommendations of the manufacturer will be followed in the calibration (every six months) of all lab instruments. The material used will be recommended by the manufacturer (for moderate complexity tests).

Control Procedures. The lab will follow the manufacturer’s recommendations when running control specimens. Only assayed control material meeting the manufacturer’s specifications will be used (for moderate complexity tests). Control specimens will be treated the same as patient specimens. Written protocol for running QC materials, recording QC results and troubleshooting out-of-control results will be followed. All actions will be documented on a Corrective Action form.

Remedial Action. Any remedial (corrective) action taken by the lab will be documented and reviewed by the lab director or designate. These records will be kept for two years.

Verification of Quantitative Methods. The lab director must ensure the accuracy and precision of all quantitative methods. Procedures may include validation studies, calibration verification (linearity studies), proficiency test results, QC results, maintenance and function checks and technical service. Each lab must establish its own protocols.

Test System QC

Each lab should follow the manufacturer’s recommendations when running control specimens. Written protocol, to be followed in performing and documenting control procedures, should establish: frequency of QC runs; use of QC material and/or electronic QC; recording QC results; protocol for accepting/rejecting QC results; remedial actions for rejected QC; documenting corrective action; protocol for system failure in event that corrective action is not successful; and policy prohibiting reporting of patient results when control values are not within range.

In addition, QC records should contain: date material run, all results, whether in range or not, corrective action logs, ranges of acceptable control values, indication of date control material was opened, expiration dates and lot numbers of QC material and reagents, daily temperature logs, maintenance/function checks and proof of QC review and assessment consistent with QA policy. *

Cathy Carver offers expertise in lab management, technical consulting, regulatory issues, continuing education and financial studies.

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