G-B 2016 Kit Instructions CAP 2016

Transcription

1 G-B 2016 Kit Instructions CAP 2016 Syphilis Serology Survey Table of Contents Kit Contents Kit Contents... 1 Important: Before You Begin... 1 Detailed Testing Instructions... 1 Reporting Your Results... 2 Biohazard Warning... 3 For Assistance... 4 Master Lists... 5 Five (1.5 ml serum) specimens G-06 G-10 Important: Before You Begin New for this Mailing None Reporting Code Changes The following manufacturers have either deleted or updated codes for this mailing: Gold Standard Diagnostics Critical Reporting Information 1. Resulting of secondary/confirmatory methods for only weakly reactive/reactive specimens and leaving presumed nonreactive specimens blank will result in a penalty on your evaluation. 2. As directed by the Centers for Medicare and Medicaid Services (CMS), laboratories are not allowed to test and report proficiency testing (PT) specimens from multiple instruments, unless that is how they routinely test patient specimens. Report the PT results as you would for your patient samples. Storage and Stability Instructions 1. Specimens are intentionally shipped ambient. Upon receipt of the kit, follow the instructions below. 2. Upon receipt, store specimens at 2-8 C. 3. Once open, specimens are stable for 5 days at 2-8 C. Detailed Testing Instructions 1. Serum has not been heat inactivated. 2. If particulate matter is present, centrifuge (3500 rpm for 10 minutes) and remove the supernatant serum for testing. If specimens appear cloudy/hazy with particulate matter upon arrival, centrifuge (3500 rpm for 10 minutes) to clear the specimen of the particulate matter. Cloudy/hazy specimens are acceptable for testing. Important: See the Biohazard Warning at the end of these instructions. Customer Contact Center option 1 (domestic) or option 1 (international) 1

2 3. Each participant is urged to use a safety pipettor device. Specimens should be treated as patient specimens unless otherwise noted. 4. Perform syphilis serology tests that are routinely performed in your laboratory. 5. Perform VDRL-CSF testing with serum specimens provided and follow your laboratory s procedure for VDRL-CSF testing. Reporting Your Results General Reporting Instructions 1. All laboratories subject to Clinical Laboratory Improvement Amendments (CLIA) regulations: If your laboratory is discontinuing testing on any CMS-regulated analyte, you must check your CMS Analyte Reporting Selections to ensure no changes are needed. You can maintain your laboratory s current reporting preferences by accessing the application via e-lab Solutions Suite 2. Each mailing, verify the accuracy of your reporting codes (eg, manufacturer, method, instrument, reagent) by reviewing the online result form or the Method Summary Page attached to the front of your result form. 3. For any testing that you do not routinely perform in your laboratory, leave all reporting areas for that test blank unless otherwise noted. 4. Exception Codes: If you must report an analytical problem for a test or individual analyte, leave the result area for that section blank and select one of the following bubbles on the result form within that section. The exception code bubble that you select will apply only to the result area(s) left blank. Documentation on the use of these codes is the responsibility of the laboratory and should be kept internally. 11 Unable to analyze Use code 11 to indicate why specimens were not analyzed (eg, instrument not functioning, reagents not available). 33 Specimen unsatisfactory To use code 33, you must contact the CAP. If you select an exception code bubble and enter data on the result form, the data will be graded. 5. Corrections can be made at any time prior to the due date printed on the result form. Review all entries for accuracy prior to online approval or before sending by fax or mail. For results that are approved online, corrections must also be done online. Faxed or mailed corrections will not be accepted. Special Reporting Instructions 1. Select the bubble preceding your result. The following are definitions of the abbreviations used on the result form: R = Reactive WR = Weakly reactive NR = Nonreactive E = Equivocal 2. If semi-quantitative (titer) results are routinely reported: for nonreactive specimens, select the bubble for Nonreactive, Titer Not Performed in the appropriate section. A blank titer response for nonreactive specimens will be marked incorrect. If you do not routinely perform titers on a specific method, you may leave the entire titer reporting section blank. 2 Syphilis Serology 2016

3 Per CLIA, as published by the United States Federal Register Proficiency Testing (PT) specimens must be tested with the laboratory s regular workload, using routine methods, and testing the PT specimens the same number of times it routinely tests patient specimens. If referral for testing is routinely performed for patient specimens, the practice cannot be followed for PT specimens. Referral is considered to be movement of the specimen from a laboratory with a CLIA identification number to another laboratory that has a different CLIA identification number. Laboratories must ensure that personnel do not share results or refer PT specimens for any reflex or testing outside their CLIA identification number. Disclaimer Survey specimens, their progeny, unmodified derivatives, or modifications thereof may not be transferred or incorporated into a program intended for sale. Survey specimens, their progeny, unmodified derivatives, or modifications thereof, reagents, and disposable equipment used in PT, when disposed of, should be autoclaved or incinerated and disposed of as hazardous waste. Disposal must follow local regulations, if more stringent than regulations enforced by the CDC or the FDA. 3. For laboratories that routinely perform titers on weakly reactive or reactive specimens by VDRL, report your results in the appropriate section. Indicate 1:1 titer for specimens that are either weakly reactive or reactive when not diluted. For the quantitative RPR card test, indicate 1:1 titer for reactive undiluted specimens in the appropriate section. 4. Note the following additional guidelines for qualitative reporting: VDRL slide, serum, should report weakly reactive, reactive, or nonreactive. RPR card, VDRL-CSF, MHA-TP/TP-PA/PK-TP/TPHA, FTA-ABS, EIA-Reagin, USR, and CMIA results must be reported as nonreactive or reactive only. FTA-ABS users should report RM (reactive minimal) results as reactive. EIA-IgG, EIA -Total Antibody, Multiplex Flow Immunoassay, and TP-LIA IgG results must be reported as nonreactive, reactive, or equivocal. 5. If your laboratory uses a test not listed on the result form, indicate your results in the Use of Other section. 6. Perform and report test results in accordance with the 1998 A Manual of Tests for Syphilis, American Public Health Association, with a published procedure recognized as a provisional or standard technique by the CDC, or according to manufacturer directions included in the product insert. Key of Terms TRUST = Toluidine Red Unheated Serum Test* VDRL = Venereal Disease Research Laboratory RPR = Rapid Plasma Reagin MHA = Microhemagglutination FTA-ABS = Fluorescent Treponemal Antibody-Absorption USR = Unheated Serum Reagin CMIA = Chemiluminescent Microparticle Immunoassay** EIA = Enzyme Immunoassay TP-LIA = Treponema pallidum line immunoassay *TRUST users: Report your results under RPR. **Chemiluminescence immunoassay (CLIA) users: Report your results under CMIA. Submitting Results 1. Results must be received at the CAP no later than midnight, Central Time by the due date on the result form. Results cannot be accepted if received after the due date. 2. Your laboratory must establish a laboratory Web account, referred to as Opting In, to submit results online. Information about opting in and a unique PIN was mailed to all laboratory directors. If your laboratory director does not have this information, please contact the CAP for a replacement letter. 3. Laboratory staff who will enter results online must first establish a personal Web account. Once a personal Web account is established, laboratory staff can request access to their laboratory s information. Biohazard Warning All Survey specimens should be treated as if potentially infectious and should be handled as if they are capable of transmitting disease. Survey specimens are prepared from blood or other source material obtained from human donors or animals. Customer Contact Center option 1 (domestic) or option 1 (international) 3

4 When working with Survey specimens, precautions should be taken to protect yourself and others from accidental exposure to infectious agents such as HIV, HBV, and HCV. HIV can be transmitted through accidental parenteral inoculation, mucous membranes, or non-intact skin contact with HIV infected blood or body fluids. HBV and HCV can be transmitted through accidental parenteral inoculation, mucous membranes, non-intact skin contact, aerosolization or ingestion. Precautions described in CDC and FDA recommendations and OSHA blood borne pathogen rules should be followed at all times when handling Survey specimens and reagents. Such precautions include the following: Gloves should be put on before opening the container and should be kept on throughout the period specimens are handled. Replace gloves if contaminated, or if their ability to function as a barrier is compromised. At high altitudes, specimens should be opened in a hood or biologic safety cabinet. There should be no eating, drinking, or smoking in the laboratory. Hands should be washed after removing gloves and before leaving the testing area. Survey specimens and reagents should be kept in separate refrigerators from those containing blood or blood components for transfusion. Survey specimens, reagents, and disposable equipment used in testing should be autoclaved or incinerated and disposed of as hazardous waste. Disposal must follow local regulations, if more stringent than regulations enforced by the CDC or the FDA. If there has been an accident in which you have been exposed to the Survey s materials, please call the CAP Hot Line at (domestic) or (international) at any time. You can access Safety Data Sheets (SDS/MSDS) by logging on to cap.org, clicking on the Laboratory Improvement tab, then Catalog and Ordering Information. For Assistance For replacement materials, please contact the CAP within 10 calendar days of the ship date for information. Provide your CAP number and contact information with all correspondence. Participants in countries serviced by a designated CAP distributor should contact their distributor s customer service department. Telephone: option 1 (Monday - Friday, 7:00 am 5:30 pm US Central Time) International Participants: option 1 Website: Address: contactcenter@cap.org cap.org CAP Surveys Program 325 Waukegan Road Northfield, IL USA 4 Syphilis Serology 2016

5 Manufacturer Master List Deleted codes None New/Updated codes 1815 Gold Standard Diagnostics (GSD) 2161 Abbott 1681 Ampcor 1123 ASI 1986 Beckman PK 2334 Becton Dickinson/BBL 2550 Biokit 2086 BioLis/Prestige 24i 2607 BioMerieux 2240 Bio-Rad 3288 Bio-Rad BioPlex Cardinal Health SP Brand 1264 Cenogenics 2270 Diamedix 2267 DiaSorin 2286 Difco 2778 EUROIMMUN 1046 Fujirebio Inc Gold Standard Diagnostics (GSD) 1350 Hemagen - Virgo 1317 Hitachi High-Technologies Corporation 1452 Human Diagnostics 2343 Immucor 2012 IVDLab 2359 Laboratory Diagnostics 2363 Lee 1630 MarDx Diagnostics 3515 Mikrogen 3190 Murex Diagnostics 1499 New Horizons 3351 Newmarket Laboratories 2631 Omega Diagnostics Limited 3030 Phoenix Bio-Tech 3352 Plasmatec Laboratory Products 1372 Pulse Scientific, Inc Randox 2252 SCIMEDX 1863 Sekisui 2104 Shield Diagnostics 2451 Siemens 1453 Span Diagnostics 2664 Stanbio 1466 Sure-Vue (Fisher) 1823 Trinity Biotech 3353 Tulip Diagnostics 1441 Wampole/Ampcor RPR 3354 Wiener Lab 2469 Zeus Scientific 0010 Other, specify on result form Inclusion on this master list does not imply US FDA approval. Customer Contact Center option 1 (domestic) or option 1 (international) 5

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