Legionella clia packet cover

Training Packet
ThyroTest® TSH
Waived
Inverness Medical
Point of Care Diagnostic Products
Better Results Mean Better Medicine®
Inverness Medical CLIA Packet
The following materials are provided to all Inverness Medical Customers. Laboratoriesperforming waived tests are expected to follow the manufacturer’s guidelines and good laboratory practice. Included in this packet are the following: CLIA Quality Control Information Letter for Waived Tests. Quality Control and Patient Record Sheet. List of Important Test Procedure Steps to eliminate sources of error. Proficiency Test Information Package: x Introduction to PT x Tips for Successful Performance x List of Proficiency Providers Test Procedure specifically written according to the standards of CLSI Guidelines.
Competency Assessment Forms for documentation of annual competencyevaluations.
Appendix: Material Safety Data Sheets (MSDS) to satisfy OSHA requirements.
02635.00”2006 Inverness Medical – BioStar Inc. All rights reserved.
Thank you for your interest in the Point of Care products from Inverness Medical. The ThyroTest® TSH has been categorized by CLIA as a waived complexity test. Whenever possible, it is good laboratory practice to use Quality Control Material when performing waived tests to ensure that the test results are accurate. Per the ThyroTestTSH Insert, the built-in quality control features a pink line in Control Zone. This control should always be seen and shows: 1) that enough volume is added, 2) that proper flow is obtained, and 3) that the antibody is reactive. If this line is missing, the test was not run correctly or failed to function correctly. The manufacturer recommends running Controls for each new lot. However, Controls should be run with a minimum frequency, depending on number of tests run in the laboratory. Each laboratory should establish its own criteria based on the following parameters: x Each new lot x Each newly opened kit (20 tests)x Each new shipment (even if from the same lot previously received)x Each new operator (an individual who has not run the tests for at least two Quality control standards are available for the validation of device functionality from commercial sources. Forms for QC documentation are available and may be provided to you by your Inverness Medical Sales Representative. If we may be of further service, please do not hesitate to call Technical Services at 800-637-3717. Inverness Medical Technical Services Office 02635.00”2006 Inverness Medical – BioStar Inc. All rights reserved.
Control and Patient Record
roTest
y
Th
Lot Number___________________Exp. Date__________
Inverness Medical recommends that external positive and negative controls be run minimally on each new
Record the Date, Patient’s Name, Patient Test Result, In Reviewed By: _________________________________________ ThyroTest® TSH Test
1. If the laboratory modifies the test system instructions, the test is considered “High Complexity” (non-waived) and subject to all applicable CLIA requirements.
2. Use only with finger stick blood drops using the pipette provided. 3. Each ThyroTest is run with two drops of fresh whole blood. Samples should be tested immediately after collection into the pipette. If the blood appears to be clotted in the pipette, a new, fresh blood sample should be taken. 4. Wipe away the first drop of blood after sticking the finger with the lancet. 5. It may be necessary to rub the finger for an additional drop of blood to fill the 6. Do NOT move the test cassette during 10 minutes. Do not read after 12 7. A test is invalid if a pink line in the Control Zone is missing. The test should be 02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved This is to verify that the office staff and personnel responsible for running the ThyroTest® TSH Test at _____________________________ have been thoroughly in-serviced on the test and the test procedure. This has included: x Review of the package insert
x Demonstration of the product assay
x Successful performance of the ThyroTest
TSH and interpretation of results
Names of the personnel who have been trained with the ThyroTest TSH Test and are responsible for reporting patient results: Signature of Medical Director(s) responsible for personnel and testing: Inverness Medical Trainer: ________________ 02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved .A Word about Proficiency Testing.
Proficiency testing (PT) is a type of external quality control. The practice of testing
unknown specimens from an outside source provides an additional means to
assure quality laboratory testing results. Although most labs perform quality
control on samples with known values, external quality control provides important
comparisons to determine the accuracy of your testing procedures.
The purpose of proficiency testing (PT) is to verify that the performance of each test site is in line with others performing the same analysis. Every four months, the PT provider sends test samples to their subscribers. The samples, whose values are unknown to the subscribers, are run by the testing personnel who return their results to the PT provider. The results are reviewed to determine whether each participant passes or fails performance levels established by federal and state agencies.
02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved Tips for Successful PT Performance
i Strictly follow the PT provider's storage or handling requirement before testing
PT specimens.
i Analyze PT specimens within the time frame provided by the PT
i Contact the PT provider promptly when specimens are received
damaged. You may be able to receive a replacement immediately.
i Avoid clerical error when filling out PT answer sheets. Be sure to enter
the correct result next to the correct analyte on the answer form.
i Remember to identify the instrument or method you are using to perform your PT so that you are graded among your peer group.
i Make copies of all answer forms before submitting them to your PT
02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved Proficiency Test Providers
American Association of
College of American Pathologists (CAP)
Bioanalysts(AAB)
Surveys Program
Proficiency Testing Service
325 Waukegan Road
205 West Levee Street
Northfield, IL 60093-2750
Brownsville, TX 78520-5596
800-323-4040
800-234-5315
American Academy of Family
College of American Pathologists (CAP)
Physicians (AAFP)
EXCEL Program
11400 Tomahawk Creek Pkwy
325 Waukegan Road
Leawood, Ks 66211-2672
Northfield, IL 60093-2750
800-274-7911
800-323-4040
American Proficiency Institute (API)
Medical Laboratory Evaluation (MLE)
1159 Business Park Drive
ACP-ASIM Services
Traverse City, MI 49686
2011 Pennsylvania Avenue, NW
800-333-0958
Suite 800
Washington, DC 20006-1834
800-338-2746
Accutest
P.O. Box 999
Westford, MA 01886
800-356-6788
Some states provide their own in-state proficiency testing programs. Please contact your state CLIA office for more information.
02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved Laboratory:_______________________________Date Implemented___________ Address:____________________________________________ ___________________________________________________ ___________________________________________________ Principle
The ThyroTest one-step, rapid TSH assay for hypothyroidism screening in adults is a lateralflow chromatographic immunoassay for the qualitative determination of human thyroidstimulating hormone (TSH) in whole blood.
Thyroid stimulating hormone (TSH), or thyrotropin, is the primary regulator of the functionalstate of the thyroid gland. Its production and release is stimulated by the hypothalamic thyrotropin-releasing hormone (TRH) and is controlled by levels of the thyroid hormones(thyroxine and triodothyronine) at the pituitary gland and possibly the hypothalamus. Serum TSH levels are raised in cases of primary hypothyroidism. The diagnosis of hypothyroidism is made by finding a low total or free T4 value and is confirmed by a raised TSH level. Mild primary hypothyroidism may be more difficult to diagnose by just measuring the level of total and free T4, because the total and free T4 value can sometimes be within the normal range. In these cases, TSH assays are useful for diagnosis since the levels of TSH are raised. In hyperthyroidism, levels of T3 and T4 are raised and TSH level is reduced.
II. Specimen
Collection/Treatment
Acceptable: Fresh, finger stick whole bloodUnacceptable: Clotted Specimens Acceptable: Pipette included in test pouchUnacceptable: Other containers Samples should be tested immediately after collection into the pipette. Patient samples, extracted samples and used test stripsshould be handled as though they are potentially infectious.
III. Reagents and Equipment
A. Reagents and Materials Provided
Test Cassette – 20 each – An absorbent membrane cassette individually wrappedin foil pouch, containing a plastic pipette for blood sample.
Dropper Bottle – 6 mL – Buffer Diluent.
Positive Control – 1 each 0.5mL – Positive TSH serum Negative Control 1 each 0.5 mL – Negative TSH serum ThyroTest TSH Controls are prepared using human serum with purified human TSH added to achieve the desired concentration levels.
CLSI ProcedurePage 1 of 7 02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved B. Materials Required But Not Provided
C. Storage
and Stability
The test kit may be stored at room temperature (15°- 30°C; 60°- 86° F): do not
freeze.
Do not use the test cassette after the date printed on the foil pouch.
Keep away from moisture, heat, or direct sunlight.
ThyroTest TSH Controls are stored at 15°-30°C (60°- 86°F) and are stable until the expiration date on the vial. After opening, the vials should be used at room temperature. The stability after opening is 30 days.
D. Quality Control
Internal Procedural Controls
ThyroTest contains built in control features. A pink line in the Control Zone should alwaysbe seen and shows: 1) that enough volume is added, 2) that proper flow is obtained, and 3) that the antibody is reactive. If this line is missing the test was not run correctly or failed to function correctly. A missing line in the Control Zone indicates an invalid test and shouldbe repeated using a new cassette. Quality controls standards are available for thevalidation of device functionality from commercial sources.
External Quality Control Testing
The manufacturer recommends that CLIA waived laboratories run Controls for each new
lot. However, Controls should be run with a minimum frequency, depending on number of
tests run in the laboratory. Each laboratory should establish its own criteria based on the
following parameters:
Each new shipment (even if from the same lot previously received) Each new operator (an individual who has not run the tests for at least two weeks) Monthly, as a continued check on storage conditions Whenever problems (storage, operator, or other) are identified Or other times as required by your laboratory’s standard QC procedures.
The Positive and Negative controls included in the kit should be run according to laboratory requirements. These controls should be run like an unknown sample. If the controls do not give expected results (Positive or Negative), patient results must not be reported, and the test should be rerun. If external controls are preferred, it is recommended that a mid to high (Positive) and a low (Negative) control be run with a minimum frequency, dependingon number of tests run in the laboratory.
If you are not running the ThyroTest under CLIA waived status, or if your local or state regulations require more frequent testing of quality control material, quality control must be performed in compliance with those regulations. Each laboratory or testing site using the ThyroTest TSH must have a CLIA Certificate of Waiver, call your state department of health for an application form. CLSI ProcedurePage 2 of 7 02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved Remedial Actions
If the test does not show any Control or Test line in the window or a smudged or partial line,
the test cassette should be discarded. Do not report the results. Run the test again with a
new cassette and follow the procedure exactly. If the second test does not show lines,
please contact Technical Services at 800-637-3717.
E. Precautions
Read instructions for use carefully before performing this test.
If the laboratory modifies the test system instructions, the test is considered “HighComplexity” (Non-waived) and subject to all applicable CLIA requirements.
Use only with finger stick blood drops using the pipette provided. Blood specimens may be potentially infectious. Avoid contact with skin by wearinggloves and proper laboratory attire. Properly handle and discard all used test devicesin an approved biohazard container.
Do not use the buffer or cassette after the expiration date printed on the outside ofeach foil pouch.
Test buffer contains a preservative that is a poison and may be harmful if swallowed.
Seek medical help if buffer is ingested.
10. The control material has been found to be non-reactive for Hepatitis-B surface antigen.
However, this product should be handled as potentially infectious. The controls contain sodium azide, which may react with lead and copper plumbing to form potentially explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up.
IV. Procedure
Blood Collection:
Each ThyroTest is run with two drops of fresh whole blood. Samples should be tested
immediately after collection into the pipette. If the blood appears to be clotted in the
pipette, a new, fresh blood sample should be taken.
Rub the chosen finger towards the tip and wipe the end of the finger with an alcohol pad. Let dry thoroughly. Alcohol will affect the test. Stick fingertip with a lancet. Follow instructions for use.
Rub the finger towards the tip for a second drop.
Hold the pipette flat and touch end of the pipette (included in the pouch) to the dropof blood.
Let blood fill to the line on the pipette. The pipette will fill to the line by itself. If may be necessary to rub the finger for an additional drop of blood to fill to theline.
Test Procedure:
1.
Remove the test cassette and pipette from the foil pouch by tearing at slot on the side of bag. Do not remove the desiccant pack. Discard the pouch.
Place the cassette on a hard flat surface with the window facing up.
Add 2 drops of whole blood directly into Sample well on the Test Cassette with the pipette provided in the pouch. Discard the pipette after use into a waste containerwhen done.
Add six (6) drops of Test Buffer into the Sample well on the Test Cassette.
Set a timer for 10 minutes. Do NOT move the cassette during this time.
CLSI ProcedurePage 3 of 7 02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved At the end of the 10 minutes, read the line(s) in the window of the cassette. Do not move the cassette until you have checked the line(s). The test can be read up to 12 minutes.
IMPORTANT: Do not read after 12 minutes
Interpretation of Test Results
Negative Result: One pink/purple colored line appears in the oval window near the Control mark. No colored line near the Test mark means the TSH level is negative, and below the cut-off of 5PIU/mL.
Positive Result: In addition to the pink/purple line by the Control mark, a second pink/purple
colored line seen near the Test mark means the TSH level is positive, and above the cut-off of
5PIU/mL. PLEASE NOTE: In addition to the pink/purple line by the Control mark ANY
PINK/PURPLE line that is seen near the Test mark of the cassette at the 10 minute time is
considered a positive result. The intensity of the line does not matter.
Invalid Result: A pink/purple line should always appear near the Control mark. If there is notpink/purple line seen near the mark, the test is invalid. Do not report the result. In this case the test should be repeated with a new cassette or call Inverness Medical Technical Services at800-637-3717.
Reporting Results
The results of this test should be reported to a physician for individual interpretation and
managing the symptoms.
VI. Limitations
Running the test at temperatures below or above room temperature (15° - 30°C; 60° - 86°F) may affect the results. Make sure the buffer and cassette are at room temperaturebefore running the test. The blood sample must be dispensed immediately after filling the pipette. If blood is clotted, collect a new sample and re-test.
TSH elevations have been reported concomitant to hyperthyroidism in patients withneoplasia of the pituitary. As with all screening assays, results should be considered presumptive until confirmed.
Results obtained from this kit should be used only as an adjunct to other diagnosticprocedures and information available to the physician.
To avoid incorrect readings, do not interpret the test results after 12 minutes.
Check the expiration date and if the test kit is expired do not use the test cassette(s).
CLSI ProcedurePage 4 of 7 02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved Sensitivity and Specificity
The following table shows the agreement of the ThyroTest TSH when compared to a laboratoryreference method using serum as the biological source for detection.
Reference Test
ThyroTest
Sensitivity = 81.25% Specificity = 98.28%Accuracy = 95.50%% Negative Predictive Value = 97.56% % Positive Predictive Value = 78.79% VIII. Precision
The precision of the ThyroTest was determined using replicate assays of samples from threedifferent serum pools, with kits from three different production lots. Each specimen sample wasrun through ten parallel assays. The data showed 100% precision for the duplicates of eachsample and 100% precision from different lots. IX. Interference Data
Other hormones and commonly found substances were tested to show that these substancesdo not interfere with the ThyroTest TSH results. CLSI ProcedurePage 5 of 7 02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved X. References
Burger, H.G., Patel, Y.C. “Thyrotropin Releasing Hormone-TSH” Clinical Endocrinology andMetabolism, Vol. 6 (1077) 83-100.
Ingbar, S.H. and Woeber, K.A. The Thyroid Gland: Textbook of Endocrinology, 6th Ed. (Williams: 1981). Chapter 4, pp. 117-243.
J.G., Endocrinology, Vol. 89 (1971): 1331-1344.
Utiger, R.D., “The Thyroid,” in S.C. Werner and S.H. Ingbar, eds. (Harper 7 Row:Hagerstown, MD, 1078) pp.196-205.
Sairam, M.R. and L.I., C.H. “Human Pituitary Thyrotropin: Isolation and ChemicalCharacterization of its Subunits, “Biochemical and Biophysical Research Communications,Vol. 51 (1973): 336-342. Shome, B. and Parlow, A. F. “Human Follicle Stimulating Hormone (hFSH): First proposalfor the amino acid sequence of the alpha subunit (hFSH alpha) and first demonstration of it’s identity with the alpha subunit of human luteinizing hormone (hLH)”, Journal of ClinicalEndocrinology and Metabolism, Vol. 3 (1974); 192-202.
Everd, D, “Disease of the Thyroid Gland”, Clinics in Endocrinology and Metabolism, Vol. 3 (1974): 425-450.
Everd, D.C. Ormston, B.J., Smith, P.A., Hall, R, and Bird, D.T. “Grades of Hypothyroidism,”British Medical Journal, Vol. 1 (1973): 657-662.
Caldwell, G., Gow, S.M., Sweeting, V.M., Rellent, H.A., Beckett G.J., Seth, J. and Toft, A.D. “ A New Strategy for Thyroid Function Testing,” Lancet, Vol. 1 (1985): 1117-1119.
10. Dussault, J.J. Ponlow, A., Letare J. Guyda, H. and Leberge, C. “TSH Measurements from Blood Spots on Filter paper: A confirmatory Screening test for Neonatal Hypothyroidism,”Journal of Pediatrics, Vol. 89 (1976): 550-552.
ThyroTest“ is a registered trademark of Thyrotec, Inc. CLSI ProcedurePage 6 of 7 02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved Test Procedure Review
CLSI ProcedurePage 7 of 7 02635.00”2006 Inverness Medical - BioStar Inc. All rights reserved ThyroTest® TSH Competency Assessment
…A Word about Personnel Competency Assessment …
According to the CLIA ’88 Rules and Regulations, laboratories possessing a certificate of waiver are only required to: 9Enroll in the CLIA program. 9Pay applicable certificate fees biennially.
9Perform only tests that have been classified as waived by the FDA or CDC. 9Follow manufacturers’ test instructions.
Currently, there are no personnel requirements that must be met by certificate of waiver laboratories. However, certificate of waiver laboratories are expected to follow good laboratory practices. Good Laboratory Practice
Good laboratory practices are a set of procedures that span all phases of testing (pre-
analytical, analytical and post-analytical) and are employed by a laboratory for the
purpose of achieving accurate and timely test results. All laboratories, regardless of
complexity, are recommended to follow these practices. At a minimum laboratories are
recommended to have:
1. A procedure manual that contains procedures for all tests performed in the 2. A system to train all employees and ensure their competence to perform laboratory 3. A system to ensure that patient preparation and specimen collection, identification, handling, and storage policies and procedures are in place and adequately followed. 4. A system to ensure that all paperwork associated with a patient’s test is handled in a manner to facilitate the timely reporting of results, including panic values, confidentiality of results, and storage of the results.
5. General policies and procedures written and followed regarding laboratory safety including the use of Universal Precautions and the prohibition of eating, drinking, or storage of food in the laboratory.
6. A system designed to oversee the storage of kits, reagents, and controls as required by the manufacturer and to ensure that when outdated they are properly disposed. 7. A system developed to monitor the use of, and interpret the results of, either the manufacturer’s built-in controls or external quality control material to ensure that the test system is operating correctly.1 Competency Assessment
Although not a requirement per CLIA law, evaluation of competency of testing personnel
is an important part of good laboratory practice. Providing regular training, appropriate
education, and evaluating and maintaining competency of testing personnel is essential
to achieving accurate test results. Evaluating and documenting the performance of the
individuals responsible for testing can be semi-annually during the first year the
individual tests patient specimens. Thereafter, annual evaluations are sufficient unless
test methodology or instrumentation changes, in which case, prior to reporting patient
test results, the individual's performance can be re-evaluated to include the use of the
new test methodology or instrumentation.
Competency Assessment Page 1 of 5 02635.00”2006 Inverness Medical – BioStar Inc. All rights reserved.
The procedures for evaluating the competency of the staff can include but are not limited to: 1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. 2. Monitoring the recording and reporting of test results.
3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
4. Direct observation of performance of instrument maintenance and function 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 6. Assessment of problem solving skills. In addition, evaluation of competency may also include a written quiz. Inverness Medical Competency Assessment Tools
As an Inverness Medical customer you are provided with the following to help maintain
and evaluate testing personnel competence:
x The Training Certificate in the CLIA packet can be used as documentation that appropriate training has been provided to all testing personnel for the ThyroTest TSHtest.
x We have provided you with a written quiz that can be administered to all testing personnel as part of their competency assessment.
x A Competency Assessment Checklist has been created that can be used to verify and document that all areas of competency for the ThyroTest TSH test have been evaluated.
1.COLA LabGuide“, General Information on Waived Tests, 11-1, 4/9/97.
Attachments:Competency Assessment Answer Key Competency Assessment Personnel Checklist Competency Assessment Quiz Competency Assessment Page 2 of 5 02635.00”2006 Inverness Medical – BioStar Inc. All rights reserved.
ThyroTest® TSH Quiz
Answer Key
The test kit may be stored at room temperature (15° – 30°C; 60° - 86F); do
not freeze.
Running the test at temperatures below or above Room Temperature (15° - 30°C; 60° - 86°) may affect results. Make sure the buffer and cassette are at room temperature before running the test. Each ThyroTest TSH is run with two drops of fresh whole blood. Samples should be tested immediately after collection into the pipette. ThyroTest TSH Controls, when unopened, are stable until the expiration date on the vial. After opening, the vials are stable for 30 days.
The ThyroTest TSH test is a categorized as a CLIA waived test. Each laboratory or testing site using the test The built in quality control feature (pink line in control zone) indicates: thatenough volume is added, proper flow is obtained, and the antibody is reactive.
A positive result means the TSH level is above the cut-off of 5 μIU/mL.
Timer should be set for 10 minutes. At the end of the 10 minutes, read theline(s) in the window of the cassette. Do not move the cassette until you have checked the line(s). The test can be read up to 12 minutes. A positive result is a pink/purple line by the Control mark, and a pink/purple line seen near the Test mark.
The ThyroTest TSH test is a one step, rapid TSH assay for hypothyroidismscreening in adults and should be considered preliminary until confirmed.
Competency Assessment Page 3 of 5 02635.00”2006 Inverness Medical – BioStar Inc. All rights reserved.
Comments/Corrective
pplicable
A
Unsatisfactory
Assessment
Satisfactory
Procedure
Testing Personnel Competency
Test Method: Thy
Evaluator:
ThyroTest® TSH Quiz
Circle T (True) or F (False) for each Question: The ThyroTest® TSH test kit requires refrigeration at 2q to 8qC.
Running the test at temperatures below or above Room Temperature (15° - 30°C; 60° - 86°) may affect results. Either serum or whole blood may be used as acceptable sample types for After the control vials have been opened they are stable for 30 days. The ThyroTest TSH test is a CLIA waived test. The built-in Quality Control feature does not indicate if the proper flow is A positive result means the TSH level is above the cut-off of 1.5 μIU/mL. Test Results should be read at 10 minutes. The appearance of a pink/purple Control Line and a pink/purple Sample The results obtained with the ThyroTest TSH test are definitive for Reviewed By:
Competency Assessment Page 5 of 5 02635.00”2006 Inverness Medical – BioStar Inc. All rights reserved.
ThyroTec, Inc
1801 Horseshoe Pike, Suite 1
Honey Brook, PA 19344
610-942-8971
Safety Data Sheet
1. Product – ThyroTest“ TSH Test Kit
2. COMPOSTION/COMPONENTS INFORMATION
hazardous components1. Sodium azide in diluent 3. HAZARDS IDENTIFICATION
N/A
4. FIRST AID
5. DISPOSITIONS AGAINST FIRE
6. DISPOSITIONS AFTER ACCIDENTAL SPILLING
7. HANDLING AND STORAGE
8. RECOMMENDATIONS FOR EXPOSURE/PERSONAL PROTECTION
9. PHYSICAL AND CHEMICAL PROPERTIES (LIQUID COMPONENTS ONLY)
10. STABILITY AND REACTIVITY
Hazardous products from decomposition: N/A 11. TOXICOLOGIC INFORMATION
12. ECOLOGIC INFORMATION
13. RECOMMENDATIONS FOR DISPOSAL
14. RECOMMENDATIONS FOR SHIPMENT
15. LEGAL INFORMATION
Labeling in conformance with EU directives: conforms 16. OTHER INFORMATION
This information cannot be considered as exhaustive but rather as guidelines.

Source: http://www.invmed.info/pub/clia/waived/waived_clia_packets/TSH_CLIA_02635.00.pdf