AQ-C 2016 Kit Instructions CAP 2016

Transcription

1 Critical Care/Aqueous Blood Gas Survey AQ AQ2 AQ-C 2016 Kit Instructions CAP 2016 Table of Contents Kit Contents... 1 Important: Before You Begin... 1 Detailed Testing Instructions... 2 Reporting Your Results... 3 Biohazard Warning... 4 For Assistance... 5 Master List... 6 Kit Contents AQ AQ2 AQ-11 AQ-15 (2 vials each) for blood gas and chemistry HCT-11 HCT-15 (2 vials each) for hematology by conductivity only One vial snapper AQ-11 AQ-15 (2 vials each) for blood gas and chemistry HCT-11 HCT-15 (2 vials each) for hematology by conductivity only One vial snapper Important: The Kit Contents lists all possible orderable programs for this mailing. Your laboratory will only receive the programs it ordered. Important: Before You Begin New for this Mailing 1. Beginning with this mailing, the result form is available in an HTML format via e-lab Solutions Suite. This improved online interface will help avoid common clerical mistakes by validating required information is entered, such as missing units of measure or methodologies. 2. Please answer the supplemental questions at the end of the result form. 3. Siemens users: The Detailed Testing Instructions have been updated. Please review them carefully before entering your results. Storage and Stability Instructions 1. Upon receipt, store unopened ampules at 2-8 C. 2. Prior to analysis, ampules should be brought to room temperature for at least 4 hours but no more than 48 hours. Do not freeze. Reporting Code Changes The following manufacturers have either deleted or updated codes for this mailing: None Program Notes i-stat users should order Surveys AQ3/AQ4. Please refer to the Surveys catalog. Important: See the Biohazard Warning at the end of these instructions. Customer Contact Center option 1 (domestic) or option 1 (international) 1

2 Detailed Testing Instructions Handling Instructions 1. Prior to use, shake the specimen vigorously for 10 seconds. Hold the ampule by the top to avoid transfer of body heat to the contents of the ampule. 2. Restore liquid to the bottom of the ampule with gentle tapping. Wait a minimum of 1 minute for foam or small bubbles to dissipate. 3. With fingers protected (using snapper, tissues, gauze, etc), carefully snap open the ampule. If a snapper is used, place it over the top of the ampule. Press to break ampule at the scoring. 4. Contents should be sampled as soon as the ampule is opened. Exposure to room air changes the po 2 and pco 2 of the liquid. Where possible, aspirate directly into the instrument with the sample probe near the bottom of the ampule. 5. For instruments designed for only direct injection: To transfer liquid from the ampule to a syringe, use an gauge needle and a 1-2 ml non-heparinized syringe. A different needle and syringe should be used for each specimen. Insert the needle into the bottom of the ampule and slowly draw liquid into the syringe. Leave some liquid in the ampule to avoid getting any bubbles in the syringe. Immediately remove the needle. With the tip of the syringe pointing down expel a few drops of liquid (along with any air bubbles at the tip of the syringe). Immediately inject the liquid into the instrument. 6. Siemens Rapidpoint 400/405/500 and Rapidlab 800/1200 series: Use the Proficiency Survey Quick Adapter (P/N ). 7. Ionized calcium: Do not correct for ph or pretreat specimens with CO Hematocrit: HCT specimens are compatible only with instruments using a conductivity method. Instrument-Specific Instructions Because the analytic behavior of the Surveys material differs from that of patient specimens, specific testing instructions may be necessary to ensure optimum results. Please see the following special instructions or contact your manufacturer for further information. 1. Epocal EPOC System: Analyze the material in the QA test mode. 2. IL GEM Premier 3000/3500: Analyze the material in the OTHER mode. Run PT in the following order: blood gas, electrolytes, hematocrit (Survey AQ/ AQ2), followed by co-oximetry (Survey SO). 3. IL GEM Premier 4000: Run 10 whole blood specimens within the 24 hours prior to sampling the PT material. From the Start New Sample tab, select Proficiency from the Sample Type menu. Note: Proficiency specimens type must be enabled in the configuration menu. Press Go. Select test panel to run Proficiency Sample. Proficiency Surveys should not be run in Patient Sample type. Run PT in the following order: blood gas, electrolytes, hematocrit (Survey AQ/ AQ2), followed by co-oximetry (Survey SO). 2 Critical Care/Aqueous Blood Gas 2016

3 4. Nova Blood Gas and CRT analyzers (all models): Analyze as proficiency specimens using the QC mode. 5. Radiometer ABL blood gas users: Do not adjust your results for elevation or barometric pressure. 6. Radiometer ABL 90 With Co-ox: How to set up the Proficiency Test button (one-time setup): Log on to the System. Select Menu > Utilities > Setup > Analysis Setup > Syringe Modes. Select the unused button in the Secondary Modes group. Check the Button is enabled box (to enable the button). Cycle through the options using the up and down arrows until Prof. Test shows in the new button. Select Close button. Instructions to run proficiency testing: Open inlet to Syringe mode. Select Prof. Test button in Secondary Modes group. Place the QC adapter on the glass ampoule. Run the specimen(s). 7. Radiometer ABL 700/800 series: Select the highest macro measuring volume and choose the sample type as Proficiency Test. 8. Roche cobas b221/b123 Systems: Analyze the material in the Blood mode. 9. Siemens Rapidpoint 400: Perform analyses of the AQ-labeled vials for blood gas and chemistry tests before analyzing HCT specimens. Manually initiate a 2-point calibration before analyzing the first HCT specimen. In addition, initiate a 1-point calibration between each analysis of HCT specimens. 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. The reporting section for estimated hemoglobin is intended for participants who normally report out estimated hemoglobin results on patients and need it to fulfill regulatory requirements. Participants should not report hemoglobin results obtained by co-oximetry in this Survey. 3. 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. 4. For any testing that you do not routinely perform in your laboratory, leave all reporting areas for that test blank unless otherwise noted. 5. 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). Customer Contact Center option 1 (domestic) or option 1 (international) 3

4 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. 22 Result is outside the method/instrument reportable range Use code 22 if you obtain a high or low result outside the reportable range of your method or instrument. Do not use this code if there is an option to select greater than or less than. 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. 6. 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. 7. Quantitative results for this Survey can now be automatically transmitted using e-lab Solutions Connect. To learn more, visit cap.org and search for e-lab Solutions Connect. 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. 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. 4 Critical Care/Aqueous Blood Gas 2016

5 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 Customer Contact Center option 1 (domestic) or option 1 (international) 5

6 Blood Gas Instrument Master List Deleted codes None New/Updated codes None 1818 Bayer Epocal EPOC System 1854 IL IL IL IL IL IL 1720/1725/1730/ IL BGE Analyzer 1778 IL Gem IL Gem Premier 2129 IL Gem Premier Plus 1455 IL Gem Premier IL Gem Premier IL Gem Premier IL Other, specify on result form 1016 ITC IRMA TRUpoint CC, BG, H ITC IRMA TRUpoint GL 2082 ITC IRMA TRUpoint H Medica Easy BloodGas/EasyStat Analyzer 1177 Nova, Nova CRT 1255 Nova Stat Profile Nova Stat Profile CCX 1448 Nova Stat Profile phox (incl. phoxbasic) 2022 Nova Stat Profile phox Plus (all models) 1251 Nova Stat Profile phox Ultra 2184 Nova StatStrip 1054 Nova STP Ultra/M 1463 OPTI CCA 2035 OPTI Lion 1101 OPTI R 1657 Radiometer ABL Radiometer ABL Radiometer ABL Radiometer ABL Radiometer ABL Radiometer ABL 80 with Co-ox 1769 Radiometer ABL 90 with Co-ox 1772 Radiometer ABL Radiometer ABL 500/600 Series (except 505 & 555) 1182 Radiometer ABL Radiometer ABL Radiometer ABL 700 Series 2017 Radiometer ABL 800 Series 1660 Radiometer BMS3, MK Radiometer EML 100/ Radiometer NPT Radiometer Other, specify on result form 1332 Roche 980 Series (ISE Mode) 1894 Roche Roche Roche 9100 Series (ISE Mode) 1509 Roche cobas b Roche Compact 2 & Roche OMNI 2080 Roche OMNI C/cobas b Roche OMNI S/cobas b Siemens Rapidlab Siemens Rapidlab Siemens Rapidlab Siemens Rapidlab Siemens Rapidlab Siemens Rapidlab Siemens Rapidlab Siemens Rapidlab Siemens Rapidlab Siemens Rapidlab Siemens Rapidlab Siemens Rapidlab Siemens Rapidpoint Siemens Rapidpoint Siemens Rapidpoint Siemens Rapidpoint Siemens Rapidpoint Siemens Other, specify on result form 2111 YSI 1500 Sport 1684 YSI Other Manufacturer/Model, specify on result form Inclusion on this master list does not imply US FDA approval. 6 Critical Care/Aqueous Blood Gas 2016

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