Plan Subject Index Number Section Subsection Category Contact Last Revised References Applicable To Detail PRINCIPLE:

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1 Subject Quality Assurance for Laboratory Testing Index Number Lab-0135 Section Laboratory Subsection Laboratory - General Category Departmental Contact Nancy Ekern Last Revised 7/27/2017 References Required document for Laboratory Accreditation by the College of American Pathologists (CAP), Centers for Medicare and Medicaid Services (CMS) and/or COLA. Applicable To Employees of: Gundersen Health System clinical Laboratories, Gundersen St. Joseph s Hospital laboratories, Gundersen Tri-County Hospital laboratories, Gundersen Boscobel Area Hospital and Clinics laboratories, and Gundersen Palmer Lutheran Hospital and Clinics laboratories. Detail PRINCIPLE: To provide a quality laboratory result as well as quality laboratory service to customers, the laboratory must ensure that all staff are adequately trained, that acceptable reagents and test methods are employed, and that the laboratory practices followed meet the acceptable standard. All records of laboratory quality assurance will be maintained as described in Lab-0230 Retention of Laboratory Records and Specimens. To ensure that all results are as accurate and timely the department will follow the practices listed below. Implementation QUALITY CONTROL: 1. Quality of patient results will be monitored at least daily, or if batched on the day of assay, through the use of quality control material. Current controls to be used for specific test may be found in the procedures for each specific test and will be described in the Quality Control section of the procedure according to Lab-0170 Quality Control. Additionally, continual overall quality will be monitored by participation in proficiency testing programs. 2. The quality control program for testing will be designed to detect deviations in quality which may affect medical interpretation. Guidelines to monitor and define acceptable performance for each analysis will be determined by the Medical Director and the Technical leader, Supervisor, Manager, or their designee according to Lab-0170 Quality Control. 3. Quality Control values provide criteria for accepting or rejecting patient results. Specific rules used to accept or reject shift and/or run quality control are found in the laboratory procedure for each specific test as described in the Quality Control section of the procedure or in Lab-0170 Quality Control. Quality Control data will be reviewed for shift and trends by careful monthly monitor and review of the cumulative data by the medical director, administrative director, manager, supervisor, or technical leader. 4. Daily quality control will be reviewed by the supervisor, technical leader, manager, director, or their designee. All necessary corrective action will be documented. Page 1 of 7

2 DETECTION AND CORRECTION OF SIGNIFICANT ERRORS: 1. On a daily basis, patient test results will be reviewed by the supervisor, technical leader or designee to detect and correct significant errors. Reviews will be designed in a manner best capable to efficiently detect significant errors. Method of choice may include review of any, or all of the following: a. Exception reports of test corrected results. b. Reported tests critical value criteria Lab-0130 Critical Reporting Values, Laboratory Reporting Protocol. c. Modified reports d. Delta checks e. Random checks of reported values as compared to instrument print outs or log sheets. f. Laboratory information system logic tables. g. Batch lists h. Instrument expert systems as described in Lab-3004 Detection and Correction of Significant Clerical Errors. 2. Questionable patient test results detected by the technologist, technical leader, their designee, nursing personnel or physician will be investigated, with re-assay or recollection, as possible steps to clarify results. a. If the new result differs from the original by more than the expected imprecision (Lab Detecting Significant Clerical and Analytical Errors) and the original report was communicated, the ordering physician or department will be notified, a corrected report will be issued (Lab-0525 Editing a Result-Lab Module) and the appropriate event report filed with the supervisor, technical leader, or manager. b. If the new result differs from the original by more than the expected imprecision (Lab Detecting Significant Clerical and Analytical Errors) and the original report was not communicated, an event report will be filed with the supervisor or technical leader. PROFICIENCY TESTING: 1. Overall accuracy of testing is monitored by participation in an appropriate, approved proficiency testing program. Proficiency testing programs are purchased from the College of American Pathologists, American Proficiency Institute, State programs or other approved surveys. 2. CLIA certified laboratories are not required to perform proficiency testing on waived tests. 3. To assure the quality of analytes, where graded proficiency testing materials are not available, alternate methods for proficiency testing will be conducted at least twice a year to validate performance. (Lab-0180 Alternate Proficiency Testing.) 3. In accordance with guidelines of College of American Pathologists, participation in ungraded proficiency survey programs may include, split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed material, clinical validation by chart review, or other suitable and documented means. 4. Results of alternate proficiency testing will be reviewed by the Laboratory Medical Director or their designee. Corrective action will be initiated in any instance where the results exceed interpretive standard described in each test procedure. The corrective action process will include completion of the Exception Response Form. The completed Exception Response Form will be reviewed, dated and signed by the Medical Laboratory Director. 5. Testing of proficiency samples will be in a manner identical to patient samples and efforts will be made to rotate proficiency testing challenges among all technical staff responsible for testing of Page 2 of 7

3 the analyte. Proficiency testing samples cannot be run in duplicate if patients are not routinely run in duplicate. 6. Proficiency test samples will be rotated among laboratory staff. Lab staff that rotate to multiple locations can only perform the survey sample at one location. 7. Intra-laboratory communication or testing comparisons are not acceptable until after the deadline for submission of data to the proficiency testing provider. 8. Proficiency testing samples, for tests performed in-house, are never sent to another laboratory. 9. All surveys are reviewed and assessed by supervisor or technical leader and Medical Director of section as indicated by signature. Any significant bias or trend is investigated. A review of the summary data is performed for all reports that are not graded due to lack of consensus, late submission, or any other reporting or recording error. Needed actions will be performed as stated below. 10. Unacceptable survey results on CAP Proficiency Surveys will be addressed by the following steps: a. Survey samples will be repeated if available. b. Previous quality control data will be reviewed. c. Corrective action will be instituted when appropriate. d. Documentation of results and action will be made on survey form and reviewed by Medical Director. e. CAP will monitor performance on proficiency testing for purposes of CAP accreditation and CLIA certification. According to established criteria, in some instances depending on analyte involved, CAP may require the laboratory Medical Director to provide additional written summary and documentation of follow up and corrective action. Proficiency Testing Exception Summary (PTES). 11. Proficiency Testing survey results will be included in the quarterly quality management review at each regional location. COMPETENCY TESTING: 1. At completion of initial training and six months following initial training, competency of all employees of the laboratory will be documented on Employee Skills Roster. 2. Thereafter, Competency will be assessed annually throughout the year and completed by year end. 3. Competency will be documented on the standardized competency forms attached to this policy. Form is the direct observation form and will reside in the employee s education folder after completion. If a written quiz is used for critical thinking/problem-solving skills it may be copied on the back or attached to the direct observation form. The quiz will have a pre-defined passing grade. Form is the observer definition, stating content of the observation and any critical thinking questions with the correct answers. This information will be retained in the Lab Admin share file. 4. Competency assessment for each employee performing non-waived testing will incorporate all of the following elements that are applicable to their duties: a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handing, processing, and testing. b. Monitoring the recording and reporting of test results. c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. Page 3 of 7

4 d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f. Evaluation of problem-solving skills. 5. POCT may use the above paper method. POCT also provides some competencies by an electronic method utilizing RALS and RALS E-quiz. Completed electronic competency dates are recorded and tracked on Gladiator Learning Zone. 6. Regional Clinics are also utilizing the electronic learning zone program in Gladiator to document and track employee competencies. 7. Proficiency testing samples will be rotated and tracked so all employees participate in testing unknowns. 8. The supervisor, technical leader or designee is responsible for the competency of all testing personnel. a. High Complexity Laboratories, (La Crosse & Regional Partner Hospitals) Testing will be assessed by a lab individual with: i. Minimum of an Associate Degree and graduated from a clinical laboratory program. ii. And 2 years of working experience in a high complexity lab testing area that they are developing, observing or evaluating. b. Moderate Complexity Laboratories, (Regional Clinics) Testing will be assessed by a lab individual with: i. Minimum of a bachelor s degree in a chemical, physical or biological science or medical technology from an accredited institution. ii. And 2 years of working experience in the lab testing area they are developing, observing or evaluating. c. If testing is waived, they may select which of the six elements should be assessed. d. They will define the section test systems, competency content, and tracking if assessed during routine work review. e. They will assure that staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently. 9. Supervisor/Technical leaders continue to provide manager with feedback if an employee appears to struggle with a certain task or test. 10. If an employee fails a portion of a competency: a. Report failure to appropriate manager immediately b. Depending on the issue, investigate previous patient results if applicable c. Depending on the magnitude, reassess or re-train and reassess. d. Have a second tech review their results before releasing until resolved e. Failed competencies must be addressed in the employees annual performance review. f. All corrective action steps should be documented on the competency forms. EQUIPMENT / INSTRUMENTATION: 1. All equipment and instruments will be verified for performance upon installation before testing begins. 2. Appropriate Instrument and Equipment functions are performed and recorded. Frequency will be at least as frequent as specified by the manufacturer. Records will be reviewed monthly by the supervisor, technical leader or designee Tolerance limits for acceptable function are defined Page 4 of 7

5 for specific instruments and equipment wherever appropriate. Defined tolerance limits must follow manufacturer s limits. 3. The manufacturer s recommended recalibration interval will be followed. Recalibration or calibration verification may be required as follows: a. A complete change of reagents that affects the range used to report patient results or QC values; or b. QC fails to meet established criteria; or c. After major maintenance or service; or d. Once every 6 months. 4. Determination for need of calibration or calibration verification will be made by technical leader or designee. The subsequent verification of calibration will be reviewed by technical leader or designee. 5. Calibration verification must be performed every 6 months for each quantitative non-waived test, as appropriate. Calibration verification requires assaying specimens having at least minimum, midpoint, and maximum values of the analytical measurement range. 6. The materials used for calibration verification should be matrix appropriate with known or determined values analyzed in the same manner as patient specimens. 7. Criteria for accepting or rejecting calibration or calibration verification are established by the medical director. 8. Successful verification certifies that the calibration is still valid; unsuccessful verification requires remedial action. QUANTITATIVE TEST METHOD VALIDATION: Good Laboratory practice requires that a new or revised method be evaluated rigorously and impartially in the laboratory according to Lab-0190 Quantitative Test Method Validation. Specific requirements for validating the functional activity of methods will include the following: 1. Analytical Measurement Range 2. Precision 3. Accuracy 4. Reference intervals 5. Quality Control All performance parameters must be documented and reviewed by the Laboratory Director before results can be reported. RECORDS: All records demonstrating quality assurance of laboratory testing, i.e. quality control, proficiency testing, worksheets, instrument print-outs/or data logs will be maintained as described in Lab-0230 Retention of Laboratory Records and Specimens. REAGENTS: 1. Reagents are stored according to manufacturer s directions. Manufacturer s directions for reagent storage will be included in the written laboratory procedure for the analyte. 2. Reagent integrity is monitored by quality control and proficiency testing. 3. New kits or reagent lot numbers will be tested before or concurrently with being placed in service. Manufacturer s directions and test policy will clarify how this will be done. Possible methods could include: Page 5 of 7

6 a. New kit or reagent tested with current reagent and quality control material. b. External quality control with each new lot # or shipment. 4. Reagents must be labeled as follows: a. Content and quantity, concentration or titer. b. Storage requirements c. Date prepared or received: On individual reagents or on the kit or box if components remain in the box. d. Date placed in service e. Expiration date. I. If manufacture expiration date changes upon opening; the new expiration date must be on the open container. II. If a reagent does not have a manufacture expiration date one must be assigned. Assigned expiration date will be based on reagent components, storage, frequency of use, and stability. A technical leader, supervisor, or manager can assist in determining the expiration interval. See individual policies for specific guidelines. 5. Expired reagents are used in rare situations (such as Manufacturer production, shipping problems, rare antisera, etc.) In these rare situations the technical leader, manager and/or lab director will have input on use. Frequency of quality control, or process change if testing method changes. Changes will be documented. 6. Calibrators are labeled, handled and stored like reagents. SPECIMEN: 1. All samples must have the proper name, unique identification number, date, and time of collection documented. Refer to Lab-1330 Patient Identification. 2. Adequate specimen identification is provided on specimen containers throughout all phases of testing. a. Unique identification may utilize LIS aliquot labels, Patient name and medical record number, Batch list with numbering system, or an independent catalog numbering system (ex. PowerPath). 3. Samples that are improperly labeled, collected, or handled should be rejected. The ordering floor or physician will be notified if a sample is rejected. Refer to LIS procedure Lab-0520 Support of Laboratory Information System for appropriate actions and documentation. 4. Refer to individual test procedures for acceptable specimens and the laboratory website for the online Specimen Collection and Handling Procedure Manual. COMMUNICATION: 1. Employee Hand-Off Communication: a. Questionable orders or results will be investigated and resolved by staff as soon as possible. b. Pending orders or sample problems will be documented and reviewed during overlap of shifts, if unresolved. Any question should be addressed and clarified. c. The laboratory now has a few options to communicate/post these changes. i. SBAR Communication Log form, Lab This form will include all written detail between shifts and remain in the department until the problem is resolved. Page 6 of 7

7 ii. Section Changes and Updates form, Lab iii. E Communication book in Gladiator iv. A temporary work aid (60 days) can also be posted in the work area to remind staff of immediate change until electronic policy has been revised and approved. v. Big Board in Chemistry 2. Employee Communication of Concerns Regarding Test Quality or Lab Safety: a. The procedure for all employees to communicate concerns or complaints with respect to the quality of patient testing and laboratory safety is Lab-0120 Laboratory Event Reporting. b. The investigation and analysis of the employee complaint and suggestions, with corrective and/or preventive action as appropriate, is according to Lab-0120 Lab Event Reporting. c. Laboratory staff may contact CAP directly if they have concerns not being addressed by GL management. Refer to Lab-0175 Objectives and Organization Pathology & Laboratory Medicine. REVIEW AND CHANGES: This document and all attached forms should be reviewed optimally on an annually basis, with 2 years as the maximum review date. Review will be done by the Technical Leader, Medical Director or designated person. Changes require retyping the document or form and review by the Medical Director. Page 7 of 7