Policies And Procedures Manual Clia 01d0665512-Books Pdf

POLICIES AND PROCEDURES MANUAL CLIA 01D0665512
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COUNTY HEALTH DEPARTMENT, LABORATORY SYSTEMS, Table of Contents. Glossary of Laboratory Terms 1, Quality Management 3. Laboratory Personnel in County Health Departments 8. Laboratory Safety 15, Miscellaneous Equipment 19, Waived Tests 25. Brightfield Microscopy 29, Vaginal Wet Mount 38, Rapid Plasma Reagin RPR 18 MM Circle Card Test 52. Darkfield Microscopy 62, Darkfield Examination for the Detection and Identification of Treponema pallidum 67.
Glossary of, Laboratory Terms, GLOSSARY OF TERMS, 1 ANALYTE A substance or constituent for which the laboratory performs testing. 2 ACCURACY State of quality of being accurate closeness of test results to the true value. and implies freedom from error also referred to as bias. 3 CALIBRATION Process by which the readings obtained from an instrument or other. measuring device in an analytical process are related to known concentrations. 4 CALIBRATOR A material solution or lyophilized preparation designed to be used in. calibration The values or concentrations of the analytes of interest in the calibration material. are known within limits ascertained during its preparation and determined by the use of an. analytical method of stated reliability, 5 CLIA The Clinical Laboratory Improvement Amendments of 1988 the federal regulatory. program governing all laboratory testing, 6 CONTROL Essentially identical specimens of stable materials usually similar in. composition and physical properties to natural specimens subjected to the same analytical. process for surveillance control monitoring to estimate the performance characteristics. accuracy precision of the analytical process The control materials are designed to be used. in the quality control process and are not used for calibration purposes The concentration of. the analytes of interest in the control material is known within limits ascertained during its. preparation and confirmed in use, 7 KIT All components of a testing system or unit that are packaged together. 8 LABORATORY A facility for the biological microbiological serological chemical. immunohematological hematological biophysical cytological pathological or other. examination of materials derived from the human body for the purpose of providing. information for the diagnosis prevention or treatment of any disease or impairment of or of. the assessment of the health of human beings These examinations also include procedures. to determine measure or otherwise describe the presence or absence of various substances. or organisms in the body Facilities only collecting and or preparing or only serving as a. mailing service and not performing testing are not considered laboratories. 9 MEAN A number that represents an entire set of numbers determined for the set in any. number of ways average, 10 PERFORMANCE CHARACTERISTIC A property of a test that is used to describe the.
quality e g accuracy precision analytical sensitivity analytical specificity reportable. range reference range etc, 11 PERFORMANCE SPECIFICATION A value or range of values for a performance. characteristic established or verified by the laboratory that is used to describe the quality of. patient results, ACHDLS Glossary of Terms 1 Revised December 2015. 12 PRECISION State or quality of being precise freedom from inconsistency or random. error closeness with which repeated determinations agree with each other and implies. freedom from variation also referred to as reproducibility. 13 PREVENTIVE MAINTENANCE A program of scheduled inspections of laboratory. instruments and equipment resulting in minor adjustments or repairs for the purpose of. delaying or avoiding major repairs and emergency or premature replacements. 14 PROFICIENCY SURVEY A program in which specimens of quality control material are. periodically sent to members of a group of laboratories for analysis and comparison of each. laboratory s results with those of other laboratories in the group through some central. organization Participation in a proficiency survey does not replace the day to day quality. control process of an individual laboratory, 15 QUALITY MANAGEMENT Sum of all those activities in which the laboratory is. engaged to ensure that information generated by the laboratory is correct Quality. management is not restricted to the development and retention of quality control charts but. rather includes all aspects of laboratory activities that affect the results produced from the. choices of methods to the monitoring of instruments to the education of personnel to the. handling of specimens and to the reporting of results The true purpose of quality. management activities is to determine how correct or incorrect the results emanating from. the laboratory are and to allow those managing the laboratory to determine whether or not. the lab is fulfilling its function satisfactorily, 16 QUALITY CONTROL Procedures performed to measure and maintain the quality of. performance in the analytical laboratory through measurement of the variability against pre. established criteria specifications correction as indicated and documentation The major. purpose of these programs is to establish analytical goals and to assist in their achievement. 17 REPORTABLE RANGE The range of test values expected for a designated population of. individuals, 18 SAMPLE In proficiency testing means the material contained in a vial on a slide or other.
unit that contains material to be tested by proficiency testing program participants When. possible samples are of human origin, 19 STANDARD DEVIATION The most common measure of statistics measuring how. widely spread the values in a data set are dispersed. 20 TARGET VALUE For quantitative tests means either the mean of all participant. responses after the removal of outliers those responses greater than three 3 standard. deviations from the mean or the mean established by definitive or reference methods. acceptable for use by the National Reference System for the Clinical Laboratory NRSCL. by the National Committee for Clinical Laboratory Standards NCCLS. ACHDLS Glossary of Terms 2 Revised December 2015, Quality Management. QUALITY MANAGEMENT, Quality management QM is an ongoing process encompassing all facets of the laboratory s. technical and nontechnical functions This includes patient preparation and specimen acquisition. preanalytical test analysis or examination analytical and test result reporting postanalytical. QM also extends to the laboratory s interactions with and responsibilities to patients physicians. and the Alabama Department of Public Health, I General Quality Management Policies. A Quality in the entire test system is of foremost importance. B All laboratory personnel must be trained properly commensurate with their positions. duties and responsibilities, C The Alabama County Health Department Laboratory Systems ACHDLS will maintain.
a quality control system to assure continued precision and accuracy of laboratory. D The ACHDLS will participate in the Centers for Medicare Medicaid Services CMS. approved proficiency testing PT program, II The Quality Management Program. The policies and procedures of the quality management program will be approved by the. laboratory director when first written with notation of approval by signature and date The. technical consultants will review the policies and procedures on a regular basis If a policy. or procedure requires a change a new policy or procedure will be written approved by the. laboratory director and distributed to testing sites The old policy or procedure will be. retained in a file at the Bureau of Clinical Laboratories County Assistance Section for a. minimum of two years, III Components of the ACHDLS Quality Management Program. A Patient Test Management, The laboratory director with the assistance of the technical consultants will monitor. and evaluate laboratory information recorded in the Complete Health Record the. patient chart used in the Alabama county health departments A monthly CLIA Lab. Report will be requested for the chart review Chart review will be conducted monthly. by a technical consultant and documented for the selected service area s county health. departments with at least 10 of one month s charts examined Records will be. maintained in the County Assistance Section of the Quality Management Division at. the Bureau of Clinical Laboratories Any errors in documentation will be addressed. and brought to the attention of the Area Nursing Directors and the Director of the. Laboratory for correction, ACDHLS Quality Management 3 Revised December 2015. B Procedure Manuals, A written procedure manual containing procedures for all activities of the ACHDLS.
will be maintained and readily available at all times to personnel in each testing site. The manual will be reviewed annually by the laboratory director and or the technical. consultants, C Quality Control QC Assessment, 1 Quality control records will be reviewed annually by a technical consultant This. review is conducted electronically and during onsite visits to all county health. department sites and is documented on the County Visit Worksheet. Documentation of these reviews will be maintained in the County Assistance. Section of the Quality Management Division at the Bureau of Clinical Laboratories. D Training Assessment See Quality Management Training Schedule on pages 6 7. 1 The technical consultants are responsible for assessing performing and. documenting the training and competency of the testing staff of the ACHDLS All. laboratory testing under CLIA is categorized as waived or nonwaived. a Waived tests performed by the county health department laboratories. Hemoglobins by HemoCue Method Occult Bloods by InSure FIT HCG by. Pregnancy Test Strep A Rapid Test and Urine Dipstick All tests are to be. performed per product insert and no competency is required for testing staff. b Nonwaived tests performed by the county health department laboratories. Darkfield Microscopy Rapid Plasma Reagin RPR and Wet Prep Microscopy. Workshop trainings and competency precedes county health department. laboratory staff performing nonwaived testing, Note All nonwaived testing staff must provide a copy of their high school. diploma per CLIA requirements, 2 Retrained and new nonwaived testing personnel must have competency twice. during their first year of training then annually thereafter. 3 Nonwaived workshop trainings are presented twice a year at the Bureau of Clinical. Laboratories, E Proficiency Testing, ACHDLS will participate in a CMS approved PT program on regulated analytes PT. results will be reviewed by testing personnel and technical consultants verifying that. all information is correct and complete before they are mailed faxed or e mailed to the. PT program Investigations of unsatisfactory PT results performance that does not. result in 100 of acceptable responses for each analyte including graded ungraded. and unregulated analytes will be documented by testing personnel and reviewed by. technical consultants and the laboratory director, F Comparison of Test Results and Method Validation.
Tests performed at multiple sites will be evaluated once a year Any test performed for. which PT is not available will be verified at least once a year and the results will be. reviewed and evaluated by the laboratory director or his her designee The results of. ACDHLS Quality Management 4 Revised December 2015, these evaluations are documented and maintained in the County Management Section. for each site, G Relationship of Patient Information to Test Results. Laboratory personnel will monitor test requests for appropriateness to the patient s age. sex and diagnosis If any test request or result appears inappropriate proper. consultation should be obtained, H Personnel Assessment. An ongoing evaluation of all testing personnel will be conducted through use of. proficiency testing results review of quality control records Complete Health Records. observation and annual competency evaluations for nonwaived testing procedures. These include wet preps RPRs and darkfield microscopy If during competency. evaluations an employee is found to be incompetent for one or more procedures the. employee will not be able to perform the test s If s he is still not competent after. reevaluation the employee cannot perform that testing until s he has attended training. for that procedure and deemed competent, 1 Blind Specimens All personnel who successfully pass RPR competency will. receive blind specimens quarterly Blind specimens will be comprised of RPR. liquid controls in screw top vials submitted to testers by Hackbarth couriers. Personnel must run the controls in the same manner as patient specimens and report. the results back to QM before the end of the testing period Specific instructions are. submitted to the testers via email and results are graded either Satisfactory or. Unsatisfactory Corrective action for personnel receiving an unsatisfactory result. two quarters in a row will be evaluated individually and may require retraining To. remain certified to run RPR s staff must run these blind specimens quarterly. I Communications, Problems that occur as a result of breakdowns in communication between testing.
personnel and the authorized individual who orders or receives the results of tests will. be documented In addition corrective actions taken to resolve problems and minimize. A written procedure manual containing procedures for all activities of the ACHDLS will be maintained and readily available at all times to personnel in each testing site The manual will be reviewed annually by the laboratory director and or the technical consultants C Quality Control QC Assessment 1 Quality control records will be

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