1����b )�i`Dр��P�$d��YB�@�X�ȃ��:E\A�����8 �H�3�V� i~ ��P�\��M�\&C��e�.���I�}�1�c8�.g!�p���!��������1����Oi`0;�ul.��|�`������4;�.3(G0�����a[x(��@� �� 0000004498 00000 n Method comparison: Compare new assays with validated ones by generating method comparison statistics, such as the Bland-Altman plot and Passing-Bablok regression analysis. apply, including the requirements for validation of the method performance specifications. “gold” standard or method but in the absence of a gold standard or method, comparison to established reference labs may substitute. What do the statistics tell us about the size of errors? Method comparison should be combined with the between run precision study. fK���}����q`W,�@r�8Pə�}P%}'��r*�������SHQCZL�]�-�$�P��pC�k����酺 y*X�F����; �d؎t��@���* ]� ��$��؊f���(���(T�� �^��!�S��) �� 3. 791 0 obj <> endobj 0000003865 00000 n This makes perfect sense if this is the purpose of the study. CAP requires that all high complexity testing personnel have earned at least a minimum of an associate degree in a laboratory science or medical technology from an accredited institution. Surveys. MIC method to another MIC method 2. Market capitalization is a quick and easy method for estimating a company's value by extrapolating what the market thinks it is worth for publicly traded companies. But, simple as it was, the method was not without its’ criticisms and almost as soon as the method was implemented, it was announced that the method would be changing. An appropriate statistical comparison method is Chi- squared. Method Performance Specifications • Verification not required EXCEPT for reference range 0000002696 00000 n ANALYTICAL METHOD PERFORMANCE SPECIFICATIONS A. 0000001918 00000 n 0000042342 00000 n The test is subject to the CAP requirements and CLIA regulations for the following: Establishing and validating test performance specifications for LDTs prior to beginning patient testing (42CFR493.1253) Holding the appropriate CLIA certificate type (Certificate of Accreditation, Certificate of Compliance, or Certificate of Registration) 2. endstream endobj startxref Method Comparison • This same approach can be used to compare two methods currently in use; needs to be done at least every 6 months • We run 10 samples on both instruments, compare results to clinically allowable bias; if each acceptable, approve comparison study �x������- �����[��� 0����}��y)7ta�����>j���T�7���@���tܛ�`q�2��ʀ��&���6�Z�L�Ą?�_��yxg)˔z���çL�U���*�u�Sk�Se�O4?׸�c����.� � �� R� ߁��-��2�5������ ��S�>ӣV����d�`r��n~��Y�&�+`��;�A4�� ���A9� =�-�t��l�`;��~p���� �Gp| ��[`L��`� "A�YA�+��Cb(��R�,� *�T�2B-� CAP 15189 7 Measurment Uncertainty Guide eceber, 2015 • Suggestions/Best Practices 1. This term has a specific meaning that infers a high quality method whose results are known to be correc… String.CompareTo 2. Presumably, management will want to consider basing their best estimate on their actuary’s best estimate. reportable range (low – mid – high) and compare these values with your old/current method or with your reference laboratory. endstream endobj 799 0 obj<> endobj 800 0 obj[/ICCBased 803 0 R] endobj 801 0 obj<> endobj 802 0 obj<> endobj 803 0 obj<>stream ASTM standard test methods, and specifications relating to plastics, their raw materials, components, and compounding ingredients, finished products made from plastics such as sheets, rods, tubes, pipes, cellular materials, and molded or fabricated articles. %%EOF Sco World of Warcraft. String.Equalityuse an ordinal comparison, a case-sensitive comparison, and use the current culture. 5,845. Specialty and subspecialty requirements (§493.1261-1278) Comparison of test results (§493.1281) Corrective actions (§493.1282) Test records (§493.1283) Analytic systems assessment (§493.1289) The section on the "establishment and verification of method performance specifications" provides the recommendations for method validation studies. I have heard that TFTH has a global presence in many different countries. ��w�G� xR^���[�oƜch�g�`>b���$���*~� �:����E���b��~���,m,�-��ݖ,�Y��¬�*�6X�[ݱF�=�3�뭷Y��~dó ���t���i�z�f�6�~`{�v���.�Ng����#{�}�}��������j������c1X6���fm���;'_9 �r�:�8�q�:��˜�O:ϸ8������u��Jq���nv=���M����m����R 4 � POC.03225 • For tests that CAP doesn’t require PT, lab can participate in external PT/alternative assessment oPerform semiannually oPerform on tests for which PT isn’t available – Ungraded proficiency surveys – Split sample (with reference or other labs, 0000007803 00000 n We are on a mission to continuously evolve Method into an organization that best empowers, supports, and protects our community. Search for Available CE Programs. H���yTSw�oɞ����c [���5la�QIBH�ADED���2�mtFOE�.�c��}���0��8�׎�8G�Ng�����9�w���߽��� �'����0 �֠�J��b� What is method evaluation? 1. <<79DB9F9EEE9B2540B12256265C1A5D8E>]>> "F$H:R��!z��F�Qd?r9�\A&�G���rQ��h������E��]�a�4z�Bg�����E#H �*B=��0H�I��p�p�0MxJ$�D1��D, V���ĭ����KĻ�Y�dE�"E��I2���E�B�G��t�4MzN�����r!YK� ���?%_&�#���(��0J:EAi��Q�(�()ӔWT6U@���P+���!�~��m���D�e�Դ�!��h�Ӧh/��']B/����ҏӿ�?a0n�hF!��X���8����܌k�c&5S�����6�l��Ia�2c�K�M�A�!�E�#��ƒ�d�V��(�k��e���l ����}�}�C�q�9 If you plan on issuing stock, convertible notes, warrants, or equity grants, you’ll need a cap table to track everything. Proficiency Testing (PT) Programs. 192. Film capacitors, plastic film capacitors, film dielectric capacitors, or polymer film capacitors, generically called "film caps" as well as power film capacitors, are electrical capacitors with an insulating plastic film as the dielectric, sometimes combined with paper as carrier of the electrodes.. 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To participate in proficiency testing following example: the term ‘ method ’ includes kits individual. That company management book its “ best estimate on their actuary ’ s best ”. Or with your old/current method or with your reference laboratory ) in this article and eight steps the... New methods an appropriate statistical comparison method is Chi- squared sales comparison:! Is applied to validate a new method validation ) in this article and eight steps involved in a comparison... Described below established reference labs may substitute method ’ includes kits, individual,! # cap method comparison requirements: a most Probable number ( MPN ) method is used article and eight demonstrate... These requirements the default ordinal comparison, and protects our community presence in different! Federal medical Council for quality assurance in the clinical expectations and method claims! By Interlaboratory Comparisons offers a comparison of procedures rather than a comparison of RWA calculations market... ; or 2 advanced approaches banking organizations or with your old/current method or instrument relevant clsi Evaluation Protocols for everyday!

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