Test Bulletin. ACL Client Services acllaboratories.com

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1 Test Bulletin Effective Effective March May 1, 2014 New Specimen Types for Chlamydia and/or Gonorrhoea (GC) Testing: Throat and Rectal ACL Laboratories will begin accepting throat and rectal specimens for Chlamydia/GC by Target Amplified Nucleic Acid Probe (Test Code CGPT), GC by Target Amplified Nucleic Acid Probe (Test Code NGPT) and Chlamydia by Target Amplified Nucleic Acid Probe (Test Code CTPT) collected using the APTIMA Vaginal Swab Specimen Collection Kit. ACL Laboratories has validated the use of the APTIMA Vaginal Swab Specimen Collection Kit (Manufacturer Catalog Number ) for throat and rectal specimens. Throat and Rectal Specimen Collection Instructions: Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down or the swab is dropped, use a new APTIMA Vaginal Swab Specimen Collection Kit. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line. For throat specimens: Depress tongue with a tongue depressor. Swab the posterior pharynx, tonsils and inflamed areas with swab. For rectal specimens: Carefully insert a swab approximately one inch beyond the anal sphincter. Gently rotate the swab to sample the anal crypts. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new APTIMA Vaginal Swab Specimen Collection Kit. Immediately place the swab into the transport tube so that the score line is at the top of the tube. Carefully break the swab shaft at the score line against the side of the tube. Immediately discard the top portion of the swab shaft. Tightly screw the cap onto the tube. Label the specimen with appropriate patient identifiers, date/time of collection and specimen source. Specimen transport can be ambient or refrigerated. Note: APTIMA Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens (white label) (Manufacturer Catalog Number ) has not been validated for throat and rectal specimens and if received, these will be tested and a disclaimer will be appended to the results. APTIMA Vaginal Swab Specimen Collection Kit (orange label) (Manufacturer Catalog Number ) is the only acceptable collection device for throat and rectal specimens validated and provided by ACL Laboratories. Test Code UDINV Test Code UDINV, Drug Investigation, will no longer be performed on blood. The only acceptable sample type will be urine. For additional information about this test and specimen sample requirements, please refer to the ACL Laboratories Directory of Services at acllaboratories.com/test-catalog/.

2 Holiday Reminder With the upcoming holiday, Memorial Day on May 26, 2014, it is important to remember that stability for certain specimens can be compromised due to transport schedules. Please check our Directory of Services on acllaboratories.com/test-cataglog/ for the most up to date collection information. If a test requires special or time sensitive handling, please call ACL Client Services at for instructions prior to collecting the specimen. Tricyclics will now be performed at ARUP Laboratories Specimen requirements: 1.0 ml (min: 0.5 ml) serum refrigerated. Separate serum from cells ASAP. Reporting Time: Final within 6 days Current Test Code New Test Code Test Name NORT NORTRP Nortriptyline AMTP AMTYP Amitriptyline and Nortriptyline CLOMIP CLOMPR Clomipramine and Metabolite IMIP IMPR Imipramine and Desipramine DESIP DESPA Desipramine DOXEP DOXEPN Doxepin and Metabolite ACL will be referring the following Drug Screens to Sterling Reference Laboratory. Specimen Requirements: 20.0 ml (min: 10.0 ml) urine ambient. Reporting Time: Final within 4 days. Current Test Code New Test Code Test Name UXTC ** UXTCSC Ecstasy Screen U6AM U6AMSC Heroin Metabolite Screen UMQ UMQSC Methaqualone Screen UPROP UPRPSC Propoxyphene Screen **NOTE: Test Code UXTC will remain available. Test Code UBETH (Alcohol, Blood) will be replaced by existing test code ALC (Alcohol, Blood). Test Code PENTOB (Pentobarbital Wisconsin Only) will be replaced by existing Test Code QNEMB (Pentobabital Illinois Only). From now on, Test Code QNEMB will be used in both states.

3 Procalcitonin Testing Test Code PCT Procalcitonin (Test Code PCT) testing will now be offered at Aurora St. Luke s Medical Center and the following Advocate Health Care sites: Christ Medical Center, Condell Medical Center, Good Shepherd Hospital, Good Samaritan Hospital, Illinois Masonic Medical Center, Lutheran General Hospital, South Suburban Hosptial, and Trinity Hospital. ACL currently offers this testing at the Illinois Central Lab in Rosemont. Procalcitonin is a calcitonin precursor that normally is produced in the thyroid. Typically, procalcitonin is seen in concentrations that are < 0.1 ng/ml. However, procalcitonin is produced in large concentrations by other body tissues in patients with systemic inflammation, particularly those caused by bacterial infections such as sepsis. Immunosuppression, including neutropenia, does not affect the production of this biomarker. Higher levels tend to correlate with more severe infections, and may be prognostic of mortality risk. Procalcitonin is generally low in viral infections, chronic inflammatory disorders, autoimmune processes, and localized infections. Procalcitonin levels tend to be significantly elevated in bacterial infections, particularly in sepsis where levels greater than 2.0 ng/ml and often greater than 10.0 ng/ml, are seen. Interpretation of PCT Values in Critically Ill ICU Patients Systemic Inflammatory response syndrome, severe sepsis, and septic shock are categorized according to the criteria of the consensus conference of the American College of Chest Physicians/Society of Critical Care Medicine. These ranges are provided for reference purposes only. PCT Concentration Interpretations Risk or Options for Further Actions PCT 0.5 ng/ml PCT ng/ml PCT > 2.0 ng/ml PCT 10.0 ng/ml Systemic infection (sepsis) is not likely. Local bacterial infection is possible. Systemic infection (sepsis) is possible, but other conditions are known to elevate PCT as well. Systemic infection (sepsis) is likely unless other causes are known. Important systemic inflammatory response, almost exclusively due to severe bacterial sepsis or septic shock. Low risk for progression to severe systemic infection Caution: PCT levels below 0.5 ng/ml do not exclude an infection. If PCT is measured very early after a bacterial challenge (<6 hours), the PCT value may still be low. PCT should then be reassessed 6-24 hours later. Moderate risk for progression to severe systemic infection Monitor patient closely both clinically and by reassessing PCT within 6-24 hours. High risk for progression to severe systemic infection High likelihood of severe sepsis or septic shock. Other non-infectious conditions can also lead to elevations of procalcitonin, including severe trauma, major burns, multi-organ failure, or major surgery. Also, patients with medullary thyroid carcinoma may have elevations in procalcitonin.

4 1-sided insert Test Bulletin May 2014 Change in Specimen Collection Tube for Culture, Blood for Mycobacteria (Test Code BLMY) Effective May 21, 2014, the specimen collection tube for Culture, Blood for Mycobacteria (Test Code BLMY) will change to a 7 ml Sodium Polyanethol Sulfonate (SPS). Please consult the ACL Laboratories Directory of Services at acllaboratories.com/test-catalog/ for additional information. Illinois Department of Public Health (IDPH) Adding Two New Tests to Newborn Screens The Illinois Department of Public Health (IDPH) is in the process of adding two additional screening tests to the Newborn Screening Panel to detect: Severe Combined Immunodeficiency (SCID) and other T-cell lymphopenias Lysosomal Storage Disorders (LSDs) SCID TESTING Interpretation: Negative, Positive or Invalid (requires new specimen) Notes for Positives: 1) Possible SCID or other T-cell lymphopenias. Immediate referral to a pediatric immunologist for evaluation and diagnostic testing is recommended. 2) Pre-term babies may have false-positive results for this test: please submit a new specimen. LSDs TESTING Interpretation: Negative, Positive or Invalid (requires new specimen) Note for Positives: Possible Lysosomal Storage Disorder with specimen sent out for second-tier DNA testing with an additional report to follow. Immediate referral to a metabolic specialist for evaluation and diagnostic testing is recommended. The reporting of these new screening tests by the Illinois Department of Public Health is scheduled to be phased in prior to July 1, SCID testing will be available first, followed by LSDs.

5 The sample type for procalcitonin testing must be constant throughout the course of patient testing; therefore, the only sample type that will be acceptable for procalcitonin assays will be heparinized plasma. Please note that this is a change from the current sample type of serum. ABO/Rh Confirmation Policy & Elimination of Blood Bank ID Bands in Wisconsin Effective Monday, May 5, 2014, ACL Laboratories began implementing a policy for a 2nd confirmatory ABO/Rh test prior to issuing type-specific red cell components for transfusion for Wisconsin. With this policy, if there is no historical record of ABO/Rh type or a different sample (collected at different day or time) is not available in the lab to perform a 2nd ABO/Rh test, the patient will be drawn to confirm their ABO/Rh type prior to issuing type-specific blood to the nursing unit. Blood will still be readily available (type-specific if 2nd confirmatory ABO/Rh completed or group O if not) for all patients. Unlike separate blood bank bands, the 2nd Confirmatory ABO/Rh policy has been shown to have a positive impact in reducing sample collection errors related to blood transfusions, and is recommended by laboratory and hospital accreditation organizations. 2nd Sample ABO/Rh policies such as this are in place at other health care institutions both locally (i.e., Froedtert Health Care) and nationally (i.e., Cleveland Clinic, John Hopkins, Beth Israel Deaconess Medical Center, Mayo Clinic, etc.). At the same time the use of the Blood Bank ID bands will be discontinued for both inpatient and outpatient transfusions. Use of Blood Bank ID bands has not been found to improve the safety of blood transfusions for patients. In fact, incomplete information on the Blood Bank ID band has resulted in numerous patients being redrawn or blood transfusions being delayed. NOTE: This Policy was implemented at Aurora St. Luke s Medical Center on November 13, 2012 and at Aurora Sinai Medical Center on November 4, Nothing will change in how physicians order Type & Screen or Prepare orders for blood transfusion. Blood will still be readily available (type-specific if 2nd confirmatory ABO/Rh completed or group O if not) for all patients. This policy does not affect the request or issuing of emergent, uncrossmatched blood for unstable, bleeding patients. If you have any questions, please contact: Michael Jay Phillips, MS, SBB(ASCP), Director, ACL WI Transfusion Services Aurora St. Luke s Medical Center Michael.Phillips2@aurora.org Annual Physician s Notice The Medicare Program encourages clinical laboratories to educate physicians regarding medical necessity and laboratory billing compliance. ACL Laboratories 2014 Annual Physician s notice is included in a separate document with this month s Test Bulletin. You can also review the notice on our website at acllaboratories.com. This annual notice specifies current Medicare requirements and ACL policies. Please review the information contained in this notice and contact Kathy Lindgren, ACL Compliance Officer, at , extension 7916 if you have any questions or concerns. Confirmation Testing on Clinical Urine Drug Tests 7 Day Limit from Collection Date Effective May 12, 2014, additional confirmation testing on clinical urine drug tests will only be available for 7 days from the collection date. For example: Urine Amphetamine collected on May 1 will be discarded on May 8. This change is aligned with industry standards for clinical toxicology testing. Please contact ACL Laboratories at for confirmation testing within 7 days of specimen collection.