Test Bulletin. Save time, money, resources, and precious blood by NOT collecting extra specimens just in case

Size: px

Start display at page:

Download "Test Bulletin. Save time, money, resources, and precious blood by NOT collecting extra specimens just in case"

Stella Carr
5 years ago
Views:

1 Test Bulletin October 2018 Save time, money, resources, and precious blood by NOT collecting extra specimens just in case ACL Laboratories has seen an increase in the number of specimens submitted without a valid test order, drawn as extra, just in case additional testing may be needed. While trying to be a good partner with our Providers ensuring good patient care, time and resources are being expended by both ACL and our Providers in an effort to ensure the patient gets all their tests performed. As a result of reviewing 6-months worth of data, ACL has determined very few tests are actually added-on to these extra specimens. Providers concur this is not a value-added process for them. In addition, collection of extra blood tubes can have an adverse effect on patients contributing to iatrogenic anemia, patient discomfort, and added risk of biohazard exposure. Extra tubes consume client, phlebotomy, and laboratory resources needed to manage the collection, processing, and disposal of these specimens. Based on this information, ACL is requesting that you collect only the specimen(s) required, which correspond to the Provider s valid order, referring to ACL s Directory of Services ( for the appropriate collection tubes and volumes of blood needed. Please DO NOT collect extra specimens for a just in case scenario. We recognize there may be some exceptional times when a provider will want extra blood collected. Please follow these guidelines when collecting extra specimen for the purpose of future add-on testing: Clearly mark the label as Extra-Hold. Specimens received marked as Extra-Hold will be stored at ACL following our current retention policy requirements. When the Provider determines additional testing is required, please contact ACL Client Services at and submit a valid order for the laboratory test. Please communicate to members of your team to NOT collect any extra specimens for a just in case testing scenario. If extra specimen is collected and you do not expect a future add-on test order, please store the specimen at your location and then discard if testing is not required. Do not forward these specimens to ACL Laboratories. We appreciate your support in this effort to best utilize our resources to provide the best patient care possible. Addendum to Previously Published September 2018 Test Bulletin Article: Activated Partial Thromboplastin Time (Test Order Code APTT) Reference Range Changes Due to unforeseen issues with obtaining reagent for validation, ACL was forced to postpone the reagent rollover from Wednesday, September 18, 2018 to Monday, October 29, 2018 at midnight. As a part of the annual Coagulation reagent rollover procedure, ACL Laboratories evaluates the sensitivity of the new reagent lot and determines if the reference ranges for PT and APTT need to be adjusted. Effective Monday, October 29, 2018 at approximately midnight (Sunday evening into early Monday morning), ACL will change the upper limit of APTT reference range results for adults from 30 to 32 seconds. Pediatric ranges will also be adjusted per the chart below. Critical result ranges will remain the same (>100 seconds or NCGD no clot detected). All PT/INR reference ranges remain the same. Table of Contents Save time, money, resources, and precious blood by NOT collecting extra specimens just in case 1 Addendum to Previously Published September 2018 Test Bulletin Article: Activated Partial Thromboplastin Time (Test Order Code APTT) Reference Range Changes 1 ACL Implements New Methodology for HIV-1 Viral Load Testing 2 ACL Implements New Methodology for HCV Viral Load Testing 2 New Specimen Requirements 3 Potential Sulfasalazine Interference with Routine Chemistry Tests 4 ACL Laboratories Implements New Advanced Hematology Technology Throughout Health System Hospitals 4 ACL Laboratories Adds Toxin EIA Testing to C. difficile Testing Algorithm 5

2 Activated Partial Thromboplastin Time (Test Order Code APTT) Reference Range Changes, continued Test Order Code APTT Description Current Reference Ranges Adult Reference Range: sec sec. Heparin Therapy therapeutic range: sec sec. Pediatric Ranges: 0-2 days: sec sec. 2-6 days: sec sec days: sec sec. 28 days 4 months: sec sec. 4 mo. 1 yr.: sec sec. 1 yr. adult: sec sec. Reference Ranges Effective Monday, October 29, 2018 For additional information regarding this test, as well as specimen collection requirements, please contact ACL Client Services at or visit our website at ACL Implements New Methodology for HIV-1 Viral Load Testing Effective Wednesday, October 24, 2018, ACL Laboratories will implement a new methodology for HIV-1 viral load testing on Test Order Codes HIVQTM and HIVCF. Abbott instrumentation will be replaced by Hologic FDA approved instrument and reagents beginning Wednesday, October 24, The new methodology detection range for HIVQTM is 30-10,000,000 copies/ml and has low limit detection of 30 copies/ml. The detection range for HIVCF is 60-10,000,000 copies/ml and has low limit detection of 60 copies/ml. Based on an ACL internal study, there is no need to re-baseline patient results between the methods. For additional information regarding these tests, as well as specimen collection requirements, please contact ACL Client Services at or visit our website at ACL Implements New Methodology for HCV Viral Load Testing Effective Wednesday, October 24, 2018, ACL Laboratories will implement a new methodology for HCV viral load testing on Test Order Codes HCVQTM and HCVCNF. Abbott instrumentation and reagents will be replaced by Hologic FDA approved instrumentation beginning Wednesday, October 24, New methodology detection range is ,000,000 IU/mL and has lower limit detection of 10 IU/mL. Based on an ACL internal study, there is no need to re-baseline patient results between the methods. For additional information regarding these tests, as well as specimen collection requirements, please contact ACL Client Services at or visit our website at 2

3 New Specimen Requirements Mosquito Borne Antibody Panel (Test Order Code MBABPN) Effective immediately, there will be a change in specimen requirements for Mosquito Borne Antibody Panel (Test Order Code MBABPN). Specimen collection requirements are as follows: Mosquito Borne Antibody Panel (Test Order Code MBABPN) Collect Transport Unacceptable Conditions Stability Current Specimen Collection Requirements Two lavender (EDTA) 3.0 ml (plasma) 3.0 ml (min: 2.0 ml) plasma refrigerated Heat inactivated specimens Hemolyzed specimen Icteric specimen Severe lipemia Contaminated samples Ambient: Unacceptable Refrigerated: 3 Days Frozen: 14 Days New Specimen Collection Requirements Effective immediately Two gold gel 5.0 ml (serum) Separate serum from cells ASAP after clotting. 3.0 ml (min: 2.0 ml) serum frozen Heat inactivated specimens Hemolyzed specimen Icteric specimen Severe lipemia Contaminated sample Ambient: Unacceptable Refrigerated: Unacceptable Frozen: 14 Days Specimens originating in Illinois testing positive for Zika, Dengue, and/or Chikungunya require confirmation at the Illinois Department of Public Health (IDPH). An IDPH Arboviral Lab Submission form, accessed at the website below, must be completed prior to sending the specimen to ACL to ensure no delay in confirmatory testing by the IDPH. An Authorization Number is not required. Specimens originating in Wisconsin testing positive may require confirmation at the Wisconsin State Laboratory of Hygiene (WSLH), at the discretion of WSLH. For additional information regarding these tests, as well as specimen collection requirements, please contact ACL Client Services at or visit our website at 3

4 Potential Sulfasalazine Interference with Routine Chemistry Tests Sulfasalazine is routinely used in the treatment of inflammatory bowel disease, ulcerative colitis, Crohn s disease and rheumatoid arthritis. ACL s chemistry instrumentation vendor has informed us that this drug may interfere with the detection system used for Ammonia causing falsely elevated concentrations (<10% - 66%) or falsely decreased Alanine Aminotransferase (ALT) concentrations (29 72%). This interference was observed at extremely high and toxic concentrations of sulfasalazine. In order to minimize this potential interference, it is recommended that venipuncture occur before administration of sulfasalazine. Additionally, Providers need to be aware of this potential source of interference, especially if laboratory results are inconsistent with the patient clinical presentation. From time to time ACL is made aware of interfering substances that may impact chemistry testing results. Manufacturers regularly provide updated Instructions for Use (IFU). These contain reference information with respect to assay performance and potential interferences. These documents are retained by the laboratory and will be used as a reference for any questions or concerns that may arise. If you have any questions or need additional information, please contact ACL Client Services at ACL Laboratories Implements New Advanced Hematology Technology Throughout Health System Hospitals ACL Laboratories will implement new advanced technology for hematology tests across hospital based laboratories throughout 2018 and early By the end of first quarter 2019, all hospital based laboratories will operate on the new hematology instrument platform. The advanced technology will allow these laboratory sites to report an automated 6 part differential, which will include the usual neutrophils, lymphocytes, monocytes, eosinophils and basophils, as well as an immature granulocyte population. The immature granulocyte population includes metamyelocytes, myelocytes, and promyelocytes. In addition, the presence or absence of nucleated red blood cells (NRBCs) will be reported on all samples with test orders for CBC analysis (ACL Test Order Codes CBCA and CBCNO). Samples flagged by the analyzer for possible increased immature granulocytes (>3 %) as well as other abnormalities will continue to have a manual slide review and manual differential performed if deemed necessary and any sample with NRBCs will have a manual slide review for confirmation on 1st occurrence. These changes apply to the automated differential only. There will be no changes to the manual differential result reporting. The manual differential components will continue to report metamyelocytes, myelocytes, and promyelocytes as separate cell types. Appropriate reference ranges will print on patient reports. This new technology and subsequent changes to result reporting will be seen in the following locations at the time period identified: October 2018 November 2018 December 2018 January 2019 February 2019 Advocate Lutheran General Hospital, Advocate Condell Medical Center, Aurora Sinai Medical Center, Aurora Medical Center Kenosha, and Aurora Medical Center Sheboygan Advocate Good Shepard Hospital, Aurora Medical Center Summit, Advocate South Suburban Hospital, Aurora St. Luke South Shore, Advocate Illinois Masonic Medical Center, Aurora Medical Center Oshkosh, Advocate Trinity Hospital, and Aurora Memorial Hospital of Burlington Aurora Medical Center Grafton, Advocate Good Samaritan Hospital, Aurora Lakeland Medical Center, Aurora Medical Center Hartford, and Aurora Medical Center of Manitowoc County Aurora Bay Area Medical Center Aurora Baycare Medical Center 4

5 ACL Laboratories Adds Toxin EIA Testing to C. difficile Testing Algorithm Effective Wednesday, November 14, 2018, ACL Laboratories will change its testing approach for the identification of Clostridioides (Clostridium) difficile. The current testing approach utilizes a molecular test to detect the presence of the C. difficile bacterium, but cannot differentiate between asymptomatic colonization and active infection, which often leads to overtreatment of patients. The new testing strategy will be an algorithmic approach that begins with the current molecular test. However, with the new algorithm all specimens testing positive in the molecular assay will now be reflexed to an enzyme immunoassay (EIA) that is designed to detect the actual toxin protein. The presence of this protein has a very strong correlation with active C. difficile disease and generally warrants treatment while the absence of this protein is often associated with colonization or milder disease that may not necessarily require treatment. Specimens testing negative for C. difficile in the molecular test will not be reflexed to the EIA assay. The decision to update the C. difficile testing approach has been a collaborative effort between ACL Laboratories and the Advocate Aurora Health Infection Prevention and Antimicrobial Stewardship teams. This decision was largely based on the Clinical Practice Guidelines for C. difficile Infection in Adults and Children released in February 2018 by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). In addition, recent changes to the reporting criteria benefit hospitals utilizing this type of testing approach (compared to a molecular test alone) when reporting hospital acquired C. difficile infections to the National Healthcare Safety Network (NHSN). The C. difficile test order name will remain the same as it is currently listed in hospital information systems, but will now contain the following two result components along with an interpretive comment: C. diff Tox by PCR (this component is equivalent to the current test) C. diff Tox by EIA (this is the new component indicative of the presence of actual toxin protein) The two tests may not be ordered individually, and the EIA test will automatically be performed on all specimens testing positive in the molecular assay. The results of the PCR test will be withheld until the EIA test is complete, and both tests will be reported simultaneously. The toxin EIA test takes approximately 30 minutes to perform; therefore, results are not expected to take significantly longer to report than they currently do. This table shows the new result format that will appear on patient charts: C. diff Tox by PCR C. diff Tox by EIA The following comment will append Not Detected Testing Not Indicated C. difficile infection is highly unlikely. Submission of additional specimens within 7 days is not recommended. Detected Not Detected* Clinical evaluation is necessary and alternative causes of diarrhea should be ruled out. Test results may represent C. difficile colonization or infection with a lower burden of disease. Most patients who are toxin PCR positive, toxin EIA negative improve without treatment, but if clinical suspicion for C. difficile infection is high, treatment may be appropriate. An infectious disease or GI consult may be considered. Detected Detected* Toxigenic C. difficile detected, which indicates a high likelihood of active C. difficile infection. Submission of additional specimens within 14 days is not recommended. *Note that additional charges will be necessary for a final test result. Please contact ACL Client Services at with any questions regarding this new testing approach. 5

Test Bulletin. The following are examples of urine chemistry tests that will no longer be accepted if submitted at an ambient temperature:

Test Bulletin. The following are examples of urine chemistry tests that will no longer be accepted if submitted at an ambient temperature: Test Bulletin ACL Laboratories Revises General Requisition Effective immediately, ACL Laboratories revised the general ACL test requisition. Highlighted updates include: November 2018 The top portion of