Troy Internal Medicine Laboratory Quality Control PDF

Troy Internal Medicine Laboratory Quality Control PURPOSE The laboratory maintains written policies and technical procedures to monitor and evaluate the quality of the analytical testing process. The quality control program is designed to detect both immediate...

Troy Internal Medicine Laboratory Quality Control PURPOSE The laboratory maintains written policies and technical procedures to monitor and evaluate the quality of the analytical testing process. The quality control program is designed to detect both immediate errors and those that occur over time. Quality control records document that controls are run whenever patient samples are tested. STANDARDS Controls are run in the same manner as patient samples. All operators who perform the test rotate performing Q.C. Controls are run prior to or concurrent with patient specimens. Testing personnel follow the manufacturers’ instructions on the number, type and frequency of controls. Reference materials specified by the manufacturer are utilized. If Q.C. results exceed acceptable limits, corrective action is taken. Patient results are not reported until Q.C. results are within acceptable range. The laboratory has established criteria for accepting or rejecting a run. Quantitative Q.C. results are plotted on a graph as a visual representation of shifts and trends, either manually or via an L.I.S. system. Controls and reagents are not interchanged between kits. Controls are run when there is a complete change of reagent, or major preventive maintenance. Two levels of controls are run for quantitative tests for each day of testing. Positive and negative controls are run for qualitative tests for each day of testing. Control results are reviewed by testing personnel. The laboratory Director or qualified designee regularly reviews Q.C. and initials the review. Records are retained for 2 years. PROCEDURES Written procedures for the performance of each test are found in the instrument Operator Manuals and product inserts, which outline the number and type of controls to be performed, as well as the acceptable limits for control results. The package inserts for assayed controls define acceptable limits for the tests and instruments being used. Qualitative controls also list acceptable results in the package insert. Control values are entered in the LIS or Q.C. log to flag any results that are outside acceptable limits. Quality control training guidelines and detailed Q.C. procedures are found on the following pages. Procedures are reviewed, signed, and dated by the Director when first adopted, and when changed or discontinued. Annual review of procedures may be delegated to the Technical Consultant or General Supervisor if there are no changes.  Quality Control Troy Internal Medicine Laboratory Policy CRITERIA FOR ACCEPTING/REJECTING A RUN See separate section within this manual LABORATORY FACILITIES AND SAFETY The laboratory space is appropriate for the type and volume of testing. This includes work surfaces, power, water, temperature and humidity controls, and waste disposal systems. The laboratory receives specimens from offices within the practice. Phlebotomy is not performed in the laboratory. Patients are not allowed in the main laboratory and there is no need for non- laboratory employees to pass through the laboratory on a regular basis. The laboratory is wired according to instrument requirements. Surge protectors are in use as needed. An eyewash station is in the lab and a fire extinguisher is within distance limits. The fire extinguisher is inspected on a yearly basis. Standards are contained in the Safety Manual. REAGENTS, CONTROLS, STANDARDS AND SUPPLIES Reagents, media, standards and controls and supplies are stored in accordance with manufacturers' specifications. Manufacturers’ instructions for the use of reagents, controls and kits are followed. Expired reagents, solutions, control materials, calibration materials and other supplies are not used and are properly discarded. Components of kits are not interchanged with those of different lot numbers unless the manufacturer states otherwise. Reagent-grade deionized or distilled water is available for use if recommended by the manufacturer. Storage of food, glucose tolerance beverages, and oral vaccines in the laboratory refrigerator designated for storage of reagents, controls or specimens is PROHIBITED. MEASURING DEVICES Measuring devices, such as volumetric, serological, semi-automated pipettes and dilutors are of certified accuracy. Preventive maintenance is performed as required. Semi-automated pipettes without a calibration mechanism are verified at least once a year. Damaged pipettes are discarded. Disposable measuring devices are used only once. Troy Internal Medicine Laboratory QUALITY CONTROL TEMPERATURE CHECKS Temperatures are recorded each day of testing for refrigerators, freezers, and room temperature. Where applicable, temperatures are also recorded for incubators and water baths and humidity checks are performed if necessary. Logs include the acceptable ranges, the actual temperatures or values, and the date and initial of the person performing the check. Thermometers are either NIST-approved or are checked against a NIST standard thermometer. Temperature check records are kept in a separate binder or folder in the lab. EQUIPMENT MAINTENANCE AND FUNCTION CHECKS Maintenance and function checks are performed on instrumentation used by the laboratory as specified by the manufacturer in the operator manual. Electronic mechanical, and operational checks are performed and documented to ensure proper test performance and reporting of results. Documentation of all maintenance performed is maintained and available for review by the laboratory staff as needed. Logs are located separately near instruments.  Quality Control Troy Internal Medicine Laboratory Criteria for Accepting/Rejecting a Run CRITERIA FOR ACCEPTING OR REJECTING A RUN The following policy establishes the laboratory's criteria for accepting or rejecting patient test results based upon the results of quality control tests. The laboratory also utilizes Westgard Rules within the instruments/LIS to determine acceptability. Abnormal control results are flagged. Control values will be ACCEPTABLE if: (1) Values read within plus or minus two standard deviations of established mean values. (2) When two controls are used; one control reads within plus or minus two standard deviations; other control reads between plus or minus 2-3 standard deviations from established mean (a random error may be expected in one out of 20 values. Control values will be considered UNACCEPTABLE and require a repeat of the quality control test if: (1) The value reads greater than plus or minus two standard deviations, when one control is used, OR (2) When two controls are used, one control is greater than plus or minus three standard deviations from the established mean OR (3) Both controls are greater than plus or minus two standard deviations from the established mean OR (4) One control is between 2-3 standard deviations on two successive runs. If upon completion of repeat quality control tests the control values are still unacceptable, open a fresh control specimen and repeat quality control tests using both old and new controls. Then, (1) If the NEW control specimen is now "in control" (within plus or minus two standard deviations of the established mean) patient sample testing may proceed. (2) If control values remain unacceptable follow trouble shooting steps in test procedure (see procedure manual) Consult with supervisor if necessary. TESTING OF PATIENT SAMPLES MAY NOT PROCEED UNTIL ACCEPTABLE CONTROL VALUES ARE OBTAINED. Technologist and/or supervisor must document, and initial corrective action taken on the quality control chart or log when: (1) Both control values are greater than plus or minus two standard deviations. (2) Any shifts occur (a shift occurs when a control result is beyond one standard deviation for four consecutive days or on one side of the mean for six consecutive days. If two controls are used, a shift occurs when both controls are beyond one standard deviation for two consecutive days or on one side of the mean for three consecutive days. (3) Any trends occur (a trend occurs when a control value increases or decreases for six consecutive days. If two controls are used, a trend occurs when both controls increase or decrease for three consecutive days. (4) Imprecision is indicated (imprecision occurs when a greater than expected number of control values exceed plus or minus two standard deviations (more than one out of 20 days) and/or exhibit a very wide scatter of control values. (5) There is a change in control value due to a change in method, instrument maintenance, reagent or standard, etc. Refer to the troubleshooting algorithm. Also read the Westgard QC article: “The out-of-control problem.”  QUALITY CONTROL Troy Internal Medicine Laboratory IQCP IQCP (Individualized Quality Control Plan) If the laboratory elects to implement IQCP it will adhere to CLIA and COLA standards. The lab will perform a risk assessment that identifies and evaluates the potential for errors. The specimen, environment, reagents, test system and testing personnel will be reviewed to ensure that the IQCP will yield results equivalent to standard Quality Control and will not compromise patient care. The Risk Assessment documentation will be saved for two years after the date that an IQCP is discontinued. While the lab has a general Quality Control plan, it will add any elements that may be specific to a test system utilizing IQCP. If the lab utilizes an IQCP, specifics will be filed with the procedure. The IQCP will be reviewed as part of the Quality Assessment Plan to ensure that it is effective. If the evaluation shows too many failures, use of the IQCP plan will be re-evaluated.  Quality Control Troy Internal Medicine Laboratory By Instrument See Instrument Manuals and Test Procedures for further information Roche Cobas and Abbott Ruby Cell Dyne At least two levels of control will be run for each analyte for each day of testing. Ruby uses three levels of controls and Roche Cobas uses two. All levels must be within range. If you are running 2 levels and one level is out, REPEAT the QC. If the QC is still out of range, follow troubleshooting according to the instrument manual and flow chart. If this does not solve the problem, alert the Supervisor and call the manufacturer for assistance. FOB, CLINITEK AND TOSOH Patient results will only be accepted if 2 levels of control are acceptable. Hematology More???? Troy Internal Medicine Laboratory Quality Control Review This form may be used to document QC review. Alternatively, review may be documented in the LIS. Date : Test/System: Comments/Corrective Action Needed: Follow-Up Instructions: Reviewed By: Date: