QUALITY ASSESSMENT PLAN

Effective Date: 
Mon, 09/23/2013
Reviewed: 
Mon, 11/06/2017
Policy: 

Principal

The quality assurance plan outlines written policies, procedures and activities designed to monitor and evaluate the quality of testing processes (preanalytic,analytic and postanalytic). Policies and procedures insure accurate reliable and prompt reporting of test results, as well as help to meet standards from regulating agencies. Ongoing quality assurance activities can detect errors, procedural lapses or divergences from goals, while also suggesting changes need in procedures or training.

The plan includes policies and procedures that describe quality control, proficiency testing, personnel training and competencies, management of test results, handling of test specimens, and the verification of accuracy of instrumentation and methodologies.

The plan also includes activities to detect prompt result reporting, to detect mishandling of specimens and to monitor the proficiency of testing personnel.

Quality Control

Controls are used according to manufacturer’s recommendations or as required by accrediting agencies for each testing procedure performed. The medical director designates the lab supervisor to monitor and review all quality control data and/or charts on a timely basis. See the QUALITY CONTROL policy located in Section VI of the LAB MANUAL for specific descriptions of quality control materials and activities.

Proficiency

Proficiency samples are provided by the American Proficiency Institute (API) on a quarterly schedule. Proficiency samples are handled in the same manner as patient samples. All testing personnel participate in analyzing proficiency samples. The medical director reviews all results and corrective actions (if needed). See the PROFICIENCY TESTING policy located in Section VI of the LAB MANUAL for more details of proficiency testing activities and monitoring.

Training and Competency

All personnel are required to undergo an extensive training period before performing testing. Training checklists and performance reviews are reviewed by the lab supervisor. Performance reviews and competency checks are performed at 6 months for new staff, and annually thereafter. Moderate to highly complex testing is only performed by licensed clinical lab scientists, while waived testing is only performed by personnel that have successfully completed training. Phlebotomy is only performed by licensed phlebotomists or clinical lab scientists. See the LABORATORY STAFF ORIENTATION, TRAINING AND ASSESSMENT policy located in Section VI of the LAB MANUAL for more details.

Test Results

All test results performed in-house are reviewed and released by clinical laboratory scientists. Abnormal or unexpected results are verified as needed. Any results questioned by the clinician are repeated and verified if possible. Critical results are called to clinicians within 30 minutes of final result. Critical result phone calls follow the format of using two forms of patient identification and having the recipient read-back the result. Documentation of the call is included in the medical record with the result. Corrected test results are called to the clinician as soon as possible. Documentation of corrected result calls is included in the medical record with the results. See the REVIEW OF TEST RESULTS policy located in Section VI of the LAB MANUAL for more details.

Lab Specimens

All lab specimens are labeled with Point and Click (MIS) labels. Hand labeled specimens may be acceptable but must have at least two forms of identification. Unlabeled or inadequately labeled specimens are rejected. Compromised specimens (clotted or hemolyzed) may be recollected if possible.  All specimens with lab orders are accessioned into Point and Click (MIS) which sends them to Orchard Harvest (LIS) system. See procedures BLOOD COLLECTION, GENERAL SPECIMEN COLLECTION AND HANDLING, QUEST LABORATORY SPECIMEN COLLECTION PROCEDURES, REJECTION OF SPECIMENS and TEST AND SPECIMEN REQUIREMENTS CHART in Section I of the Laboratory Manual for further information.

Accuracy of Instruments and Methods

All instruments and methodologies are validated before being adopted into use for routine patient testing. The validation consists of precision testing, correlation with a previously verified method and verification of linearity (if quantitative results are involved). Established instruments and methods are verified to be accurate through the use of Interlaboratory Quality Assurance Programs (IQAP) when available, quarterly proficiency testing and biannual calibration verification (where applicable). See procedures, EVALUATION OF AUTOMATED TEST METHODS, LINEARITY TESTING (REPORTABLE RANGE) CALIBRATION VERIFICATION, PROFICIENCY TESTING and QUALITY CONTROL AND ASSESSMENT in section VI of the Laboratory Manual for further information.

 

QUALITY ASSURANCE ACTIVITIES

Quality assurance activities are the ongoing studies or monitoring of lab processes in order to measure the performance or effectiveness of protocols in relation to goals set. These activities may be ongoing or may change periodically to meet the needs and the goals of lab management.

Turn around times

Turn around times or TAT is usually perceived as the time it takes once a specimen is received in the lab to the time a final result is generated. It is desirable to decrease the TAT for testing that is needed urgently (STAT) so as to expedite patient care. Monitoring TAT can help facilitate corrective actions where the TAT does not meet goals and can lead to overall changes in procedures and personnel in order to maximize efficiencies. The lab will monitor STAT in-house CBCs and STAT urine dipsticks for TAT during the current year.

Unlabeled or mislabeled specimens

Mislabeled specimens (specimens labeled with the wrong patient’s name and/or identification) can lead to serious errors in patient care. Unlabeled specimens causes delays in specimen processing and can lead to mislabeled specimens. The lab will monitor and investigate each instance of mislabeled or unlabeled specimens. The goal will be to decrease the number of incidents to zero.

Accuracy of Test Results

Inaccurate or erroneous lab results can lead to serious errors in patient care. Erroneous lab results can be caused by typographical errors, mislabeled specimens and/or instrument malfunction. All erroneous lab results must be corrected and the clinician notified promptly. Such errors are documented in the problem log.

Quality Improvement

Projects are to be undertaken to assess the quality of certain processes and procedures during the course of the year. The projects will ascertain to measure the quality of the process in terms of sensitivity, specificity or timeliness. It will also be assessed as to whether the process can be improved by implementing various changes or having staff focus on the issue. Examples of such past QI projects are the Wet Mount vs Trichomonas Culture project (improve sensitivity) or the  Urine Leukocyte Esterase vs Manual WBC Count project (improve accuracy, sensitivity and utilization).