June Beaker go-live updates. Billing and compliance. Chemistry. Drug screen testing. Referral Testing. Website

Transcription

1 June 2014 Beaker go-live updates Blood Bank and Referral Testing (SendOuts) Anatomic pathology go-live rescheduled Billing and compliance Referral testing pricing changes Chemistry New HIV testing algorithm Drug screen testing Urine drug screen test menu revised Referral Testing New orderable tests Website Test catalog updates in progress

2 BEAKER GO-LIVE UDPATES Blood Bank and Referral Testing live on Beaker On June 13th, the Allina Health Laboratory Blood Bank and Referral Testing (SendOuts) departments went live on the new Beaker LIS. With the Referral Testing go-live, several new tests were made orderable, and no longer require use of the LAB994 generic test code. A list of the affected tests is included in the referral testing section. What does this mean for you? Clients using Excellian and Ultra/Beaker You should be receiving Beaker labels, rather than Ultra labels, for Blood Bank testing along with any tests referred out to other testing laboratories. Only the AP departments (Cytology, Cytogenetics, Flow Cytometry, Histology and Molecular Diagnostics) and select clinical testing (Peripheral Morphology, Bone Marrows and Kleihauer Stains) will remain in Ultra. Follow the Beaker processes for the specimens generating Beaker labels, and continue to follow current processes for the testing that remains in Ultra. Clients ordering using manual requisitions Reports for blood bank and referral tests will now appear in the new Beaker report format. Only the AP departments (Cytology, Cytogenetics, Flow Cytometry, Histology and Molecular Diagnostics) and select clinical testing (Peripheral Morphology, Bone Marrows and Kleihauer Stains) testing will remain in Ultra and report in the Ultra format. Examples of Beaker reports can be viewed on our website at allinahealth.org/laboratory. Anatomic pathology go-live rescheduled In order to allow sufficient time for thorough testing and validation of the new system prior to implementation, Allina Health has made the decision to reschedule the Central Laboratory Anatomic Pathology (AP) Beaker go live to Friday August 1st. Departments affected by this include; Cytogenetics, Cytology, Flow Cytometry, Histology and Molecular Diagnostics. In addition to this, the Bone Marrow and Peripheral Blood Morphology tests will also transition to Beaker on August 1st. 2

3 BILLING AND COMPLIANCE Referral Testing performing laboratory and pricing changes As a part of our Referral Testing laboratory transition to our new LIS, Beaker, that occurred on May 30th, several tests have been changed to now go to, or through, Mayo Medical Laboratories (MML). Our test catalog has been updated to reflect this information. Test Name: Chlamydia pneumoniae DNA PCR Test Code: LAB2467 [ ] (MML: FCPD) CPT: List Price: $ Test Name: 68 KD (HSP-70) Antibody Test Code: LAB5519 [ ] (MML: F68KD) CPT: List Price $ Test Name: Plasminogen Chromogenic Test Code: LAB994 (MML: PSGN) CPT: List Price $47.20 Test Name: T3, Reverse Test Code: LAB123/T3R [ ] (MML: RT3) CPT: List Price: $32.30 We have received notice of a fee change for the Polio Immune Status Assay (LAB816) referred to Focus Diagnostics via Mayo Medical Laboratories, effective June 19th. The fee for this assay decreased from $ to $ Test Name: Polio Immune Status Test Number: LAB816 Performing Lab: Focus via Mayo Medical Labs (FPOLS/91469); R-MM CPT Codes: x 3 Old Fee: $ New Fee: $

4 Allina Health Laboratory has also received notice from the University of MN Physicians Outreach Laboratory of fee changes which are effective July 1, The affected tests, along with the CPT codes, current and new pricing, are listed below. Panel Name Order Code LAB # Alternate Name Current Price NEW Price (Eff. 7/1/14) Activated Protein C Resistance APC $49.70 $ Anti-Leukocyte Antibodies PRA $ $ ***HLA ABY Class I $ $ ***HLA ABY Class II $ $ Cyclosporin A UCY $36.70 $ HLA ABC Typing LAB HLA $ $ LS Ratio, PG and DSL LAB (Reflex for Lamellar Body Count) FL3 $ $ ***L/S Ratio $96.00 $ ***Phosphatydl Glycerol $75.50 $ ***DSL $ $ Rapamycin RAP $45.30 $ Tacrolimus F50 $55.00 $ CPT 4

5 CHEMISTY HIV 1/2 antigen/antibody combo & HIV differentiation test algorithm On April 12, 2014 Allina Health Laboratory converted to a new testing algorithm for the diagnosis of HIV infection. The new algorithm meets the new Draft Recommendations as proposed by the Centers for Disease Control which have been shown to improve detection of acute HIV infection (first three months), a period when patients have high circulating levels of virus and are highly infectious. The new algorithm begins with the Abbott Architect HIV Ag/Ab Combo 4th generation immunoassay. This is an FDA-approved assay which detects circulating IgM and IgG antibodies to both HIV-1 and to HIV-2, and also detects antibodies to the p24 antigen. This screening immunoassay produces a positive result if antibodies to any of the three tested components (HIV-1, HIV-2 or p24 antigen) are present, but does not differentiate between them, so a positive result for any of the three tested components is followed by a confirmatory BioRad Multi-spot HIV-1/HIV-2 differentiation immunoassay. Possible results are outlined in graphic form (from the CDC Draft Recommendations) below along with commentary from the CDC regarding interpretation of results (#1-5). This is followed by a more detailed summary of Allina Health Laboratory reported results. 5

6 1. An FDA-approved 4th generation HIV-1/2 immunoassay (IA) should be used as the initial test, to screen for acute HIV-1 infection and for established infections with HIV-1 or HIV Specimens with a reactive 4th generation IA (or repeatedly reactive, if repeat testing is recommended by the manufacturer) should be tested with an FDA-approved 2nd generation antibody IA that differentiates HIV-1 antibodies from HIV-2 antibodies. 3. Persons whose specimens give positive results on the initial IA and HIV-1/HIV-2 antibody differentiation IA should be considered positive for HIV-1 or HIV-2 antibodies and should initiate medical care that includes laboratory tests (such as viral load, CD4 determinations, and antiretroviral resistance assays) to confirm the presence of HIV infection, to stage HIV disease, and to assist in the selection of an initial antiretroviral drug regimen. [DHHS Guidelines] 4. Specimens that are reactive on the initial assay and negative on the HIV-1/HIV-2 antibody differentiation IA should be tested with an FDA-approved nucleic acid test (NAT) for HIV-1 RNA. Under these circumstances, a reactive NAT result indicates the presence of acute HIV-1 infection. A negative result indicates the absence of HIV-1 infection, either a falsepositive result on the initial IA or rarely, recent HIV-2 infection. If HIV-2 infection is a possibility, a NAT for HIV-2 DNA can be considered. However, HIV-2 infection is rare in the United States, and there is no FDA-approved NAT for HIV This same testing algorithm beginning with a 4th generation immunoassay should be followed for specimens from persons with a preliminary positive rapid HIV test result. Summary of Allina Health Laboratory testing algorithm: Architect HIV Ag/Ab Combo Assay Result: Negative, no evidence of HIV infection based on clinical information Re-test Architect HIV Ag/Ab Combo Assay result: Positive differentiation Assay reflex to BioRad Multi-spot HIV-1/HIV-2 6

7 HIV-1/HIV-2 Differentiation assay results: HIV-1 HIV-2 Interpretation Positive Non-reactive Positive for HIV-1 Antibodies. Suggest follow-up testing: HIV-1 RNA Quant (HVL) Non-reactive Positive Positive for HIV-2 Antibodies. Suggest follow-up testing: HIV-2 DNA (Mayo) Non-reactive Non-reactive HIV Ag/Ab combo test is positive, presumably due to presence of HIV p24 Ag, non-reactive for both HIV-1 and HIV-2 antibodies, Suggest follow-up testing: HIV-1 RNA Quant (HVL) Indeterminate Indeterminate HIV Ag/Ab combo test is positive, possibly due to presence of HIV p24 Ag as differentiation assay is indeterminate for both HIV-1 and HIV-2 antibodies, Suggest follow-up testing: HIV-1 RNA Quant (HVL) Indeterminate Positive Indeterminate for HIV-1 and positive for HIV-2, Suggest follow-up testing: HIV-1 RNA Quant (HVL), HIV-2 DNA (Mayo) Positive Indeterminate Indeterminate for HIV-2 and positive for HIV-1, Suggest follow-up testing: HIV-1 RNA Quant (HVL) Positive Positive HIV positive but undifferentiated, additional testing recommended Suggest follow-up testing: HIV-1 RNA Quant (HVL) Positive for HIV-2 Antibodies, HIV-2 DNA (Mayo) 7

8 URINE DRUG SCREENING Urine drug screen test menu revised To better address the complexities of drug screening for different patient groups, Allina Health Laboratory has revised the urine drug screen test menu. This information does not include maternal/infant drug screening, which has separate requirements. The revised test menu consists of 4 drug screen panels: 1. Urine drugs of abuse presumptive screen, LAB597. A preliminary screen with limited clinical utility. 2. Limited Compliance Drug Monitor, LAB NEW - Optimized for monitoring patients in chemical dependency programs. 3. Comprehensive Compliance Drug Monitor, LAB8742. Comprehensive drug screen. Preferred test for monitoring patients in pain management programs. 4. Synthetic cannabinoids qualitative screen, LAB Detects bath salts, K2, Spice. Important: Drug screening at Allina Health Laboratory cannot be used for any legal purpose, with the exception of certain maternal/infant specimens that are collected through special procedures. The following information includes comparison charts, lists of drugs detected, and sample reports. Urine drugs of abuse presumptive screen, LAB597 - turnaround time stat (1 hour from arrival in lab) or routine (same day). Allina Health Laboratory receives many questions about the reliability and interpretation of this drug screen. This drug screen provides only a preliminary presumptive result and has limited clinical utility. Due to many cross reactions inherent in the rapid screen technology, this screen is not preferred for chemical dependency or pain management monitoring. When this test is ordered, consideration and professional judgment must be applied in evaluating a preliminary positive result. Confirmation testing should be ordered on any unexpected presumptive positive result; it is important to understand that many of these results will NOT confirm on further analysis by chromatography and mass spectrometry. For example, only 40-50% of screening positives for opiates or amphetamines will confirm. Important points to remember about this drug screen (and all rapid presumptive drug screens and cup tests): 1. This screen cannot distinguish between abused drugs and many common prescribed and over-the-counter medications. 2. Certain foods or legitimate medications may interfere with screening tests and cause false positive results. 3. It is not possible to predict all interferences and false positive reactions because of individual differences in medications, drug metabolism, and diet. 8

9 4. The number of screening positives that confirm on further testing is as low as 40%, depending on the drug and patient population. Do not assume that a presumptive positive result is real. Order confirmation testing if the result is unexpected. Limited Compliance Drug Screen, LAB 12507, *NEW* - turnaround time 3-5 days. This screen is the preferred test for monitoring patients in chemical dependency programs. The screen includes alcohol metabolites and important drugs of abuse. Confirmations are automatically performed for positives except for THC (a separate order would be required if confirmation is needed.) Comprehensive Compliance Drug Monitor, LAB turnaround time 5-7 days. This screen is comprehensive and preferred for monitoring patients in pain management programs and other medical indications for nonemergency comprehensive screening. Results are definitive and confirmed. The screen includes over 170 drugs in 22 classes. Quantitative results (normalized to creatinine) are reported for many drugs. Synthetic Cannabinoid (K2, Spice, bath salts) Qualitative Screen, LAB turnaround time 5-7 days. Synthetic cannabinoids such as K2, Spice, and bath salts require special technology for detection and are not included in the other screening panels. 9

10 ALLINA HEALTH LABORATORY - REVISED URINE DRUG SCREENING TEST MENU TAT Performing laboratory Description Automatic confirmations In-House Rapid Presumptive Screen LAB597 presumptive screen only ROUTINE (same day) or STAT (1 hour from receipt in laboratory) Limited Compliance Screen *NEW* LAB12507 for monitoring chemical dependency patients ROUTINE only. Cannot order stat. 3-5 days. Comprehensive Drug Screen & Compliance Monitor LAB8742 (aka ToxAssure or Med- Watch) Pain compliance and nonemergency comprehensive drug screening ROUTINE only. Cannot order stat. 5-7 days Synthetic Cannabinoid Qualitative Screen LAB12396 K2, Spice, "bath salts" ROUTINE only. Cannot order stat. 3-5 days. Allina Health Laboratory MedTox MedTox MedTox Clinical utility is limited. Should be ordered only by providers who understand the limitations of antibodybased drug screens. Positive results must be interpreted with caution. Screening results are preliminary only; many screening positives will NOT confirm on further testing. Confirmation testing should be ordered for any unexpected positive (or negative) results. NONE. Confirmations are NOT automatically performed and must be ordered separately. 5-7 day turnaround time for confirmations. Routine screening of patients in the chemical dependency program. Included and automatically performed, except THC. (Confirmation for THC must be specifically ordered if needed.) Routine comprehensive drug screening for compliance monitoring in pain management or other medical indications where comprehensive screening is needed. Unnecessary, results are comprehensive and definitive. Detection of synthetic cannabinoids Results are confirmed. Reporting Qualitative results (presumptive positive/ not detected) Qualitative results (positive/negative). Qualitative (pos/neg) and Quantitative (value normalized to creatinine for many drugs) Qualitative. (For quantitative results, order LAB12521) 10

11 COMPARISON CHART: GENERAL DRUG SCREEN PANELS AVAILABLE FROM ALLINA HEALTH LABORATORY Drugs of Abuse LAB597 NEW Limited Compliance Screen LAB12507 Comprehensive Compliance Drug Screen (ToxAssure) LAB8742 DRUG DETECTION THRESHHOLD (ng/ml) DRUG CLASS DRUGS REPORTED Ethyl Glucuronide Not included 250 *Opiates: codeine, hydrocodone, hydromorphone, morphine, dihydrocodeine Etheyl Sulfate Not included 100 *Oxycodones: oxycodone, oxymorphone Amphetamines *Buprenorphine: buprenorphine, norbuprenorphine Methamphetamine 500 No separate test, metabolizes to amphetamine *Methadone: methadone, EDDP Barbiturates *Amphetamines: methamphetamine, amphetamine, methylenedioxymethamphetamine (MDMA), methylenedioxyamphetamine (MDA), methylenedioxyethylamphetamine (MDEA) Benzodiazepines *Cocaine MTB: cocaine, benzoylecgonine, cocaethylene Cocaine Metabolite *Benzodiazepines: Fentanyl Not included 1 "Opiates" includes: Other Hallucinogens: *Cannabinoids/ THC: Codeine Antidepressants: Morphine Barbiturates: alprazolam, alpha-hydroxyalprazolam, chlordiazepoxide (as metabolites), clonazepam, 7-aminoclonazepam, clorazepate (as metabolite), desalkylflurazepam, diazepam, desmethyldiazepam, lorazepam, midazolam, oxazepam, temazepam, alpha-hydroxytriazolam ketamine, phencyclidine Heroin *Ethyl Alcohol: ethyl alcohol 9 -carboxy-tetrahydrocannabinol (carboxy-thc) amitriptyline, amoxapine, 8- hydroxyamoxapine,bupropion, citalopram, desmethylcitalopram, escitalopram, clomipramine, desmethylclomipramine, desipramine, desvenlafaxine, doxepin, desmethyldoxepin, duloxetine, fluoxetine, norfluoxetine, fluvoxamine, imipramine, maprotiline, mirtazapine, nefazodone, nortriptyline, protriptyline, sertraline, desmethylsertraline, trazodone, trimipramine, venlafaxine, desmethylvenlafaxine amobarbital, barbital, butabarbital, butalbital, mephobarbital, pentobarbital, phenobarbital, secobarbital, thiopental 11

12 Drugs of Abuse Limited Compliance Screen Comprehensive Compliance Drug Screen (ToxAssure) LAB8742 DRUG DETECTION THRESH- DRUG CLASS DRUGS REPORTED Hydrocodone Sympathomimetics: ephedrine, methcathinone, methylphenidate, phenmetrazine, phentermine, phenylpropanolamine, pseudoephedrine Hydromorphone *Fentanyl and Analogs: fentanyl, norfentanyl, sufentanil, alfentanil Dihydrocodeine *Other Opiodes: butorphanol, levorphanol, meperidine, normeperidine, nalbuphine, naltrexone, pentazocine, propoxyphene, norpropoxyphene, tapentadol, tramadol, O- desmethyltramadol, N- desmethyltramadol, 6MAM (Heroin-Specific) Not included 10 Anticonvulsants: carbamazepine, gabapentin, lamotrigine, levetiracetam, oxcarbazepine MHD, phenytoin, pregabalin, primidone, rufinamide, tiagabine, topiramate, zonisamide Oxycodone Muscle Relaxants: PCP (Phencyclidine) 25 Not included Other Sedative/ Hypnotics: THC Metabolite Antidepressants: Methadone Antipsychotics: baclofen, carisoprodol, cyclobenzaprine, meprobamate, metaxolone, methocarbamol, orphenadrine, tizanidine eszopiclone, zaleplon, zopiclone, zolpidem amitriptyline, amoxapine, 8- hydroxyamoxapine,bupropion, citalopram, desmethylcitalopram, escitalopram, clomipramine, desmethylclomipramine, desipramine, desvenlafaxine, doxepin, desmethyldoxepin, duloxetine, fluoxetine, norfluoxetine, fluvoxamine, imipramine, maprotiline, mirtazapine, nefazodone, nortriptyline, protriptyline, sertraline, desmethylsertraline, trazodone, trimipramine, venlafaxine, desmethylvenlafaxine aripiprazole, chlorpromazine, clozapine, norclozapine, fluphenazine, haloperidol, loxapine, 8- hydroxyloxapine, mesoridazine, molindone, olanzapine, perphenazine, pimozide, prochlorperazine, quetiapine, risperidone, thioridazine, thiothixene, trifluoperazine, ziprasidone 12

13 DRUG Drugs of Abuse LAB597 Limited Compliance Screen LAB12507 DETECTION THRESHHOLD (ng/ml) Comprehensive Compliance Drug Screen (ToxAssure) LAB8742 DRUG CLASS Propoxyphene Not included 300 Analgesics/NSAIDS Buprenophine 10 5 Antihistamines: Tramadol Not included 200 Local Anesthetics: Miscellaneous: DRUGS REPORTED acetaminophen, ibuprofen, ketoprofen, naproxen, oxaprozin, salicylate brompheniramine, chlorpheniramine, diphenhydramine, doxylamine, hydroxyzine, promethazine, pyrilamine, triprolidine bupivacaine, lidocaine, mepivacaine, procaine atenolol, benztropine, caffeine (large amounts), clonidine, dextromethorphan, dextrorphan, diltiazem, guaifenesin, metoprolol, propranolol, theophylline, verapamil 13

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21 REFERRAL TESTING New orderable tests With the transition of our Referral Testing department to our new LIS, Beaker, a group of tests previously requiring use of our generic ordering code (994/MSO) were made orderable with unique codes. The Allina Health Laboratory test catalog has been updated with this information, and the manual requests forms are also being updated. As additional tests are built with ordering codes in the Beaker system, further communication will be shared. Performing Lab Performing Lab Code NEW AHL Ordering Code Test Name Mayo AMH LAB12474 Antimullerian Hormone (AMH), Serum Mayo AVOC LAB12498 Avocado, IgE MedTox LAB12519 Barium, Blood MedTox LAB12517 Chromium, 24 Hr Urine MedTox LAB12463 Chromium, Serum MedTox LAB12518 Cobalt, Blood Mayo CBUR LAB12495 Cocklebur, IgE Mayo CYSQN LAB12392 Cystinuria Profile, Quantitative, 24 Hour, Urine Mayo SAM LAB12504 Entamoeba histolytica Antibody, Serum MedTox 2839 LAB12514 Ezogabine (Retigabine), POTIGA Mayo GPEP LAB12477 Green Pepper, IgE Mayo HALI LAB12478 Halibut, IgE Mayo IODU LAB12465 Iodine, Random, Urine Mayo MNU LAB12390 Manganese, 24 Hour, Urine Mayo MHRP LAB12484 Mycoplasma hominis, Molecular Detection, PCR LipoScience 600 LAB12480 NMR Lipoprofile LipoScience 630 LAB12481 NMR Lipoprofile Bostwick PCA3PLUS LAB12479 PCA3 Plus MedTox LAB12516 Sulfonylurea Screen, Qt, Serum/Plasma MedTox LAB12515 Sulfonylurea Screen, Qt, Ur Mayo URRP LAB12485 Ureaplasma species, Molecular Detection, PCR Mayo VORI LAB12475 Voriconazole, Serum Mayo BENW LAB12487 White Bean, IgE 21

22 WEBSITE CEU DVD s Available for Checkout Allina Health Laboratory sponsors quarterly continuing education presentations in the Twin Cities area. For those unable to attend, we record each presentation and make the DVD/videotapes available for viewing. Upcoming CEU event information as well as a listing of available presentations and a DVD Request Form can be found under the Continuing Education heading on our website homepage at allinahealth.org/laboratory. Thank you for choosing Allina Health Laboratory We value your business! 22