Mid America Clinical Laboratories

The Regional Laboratory for Mid America Clinical laboratories (MACL) is located on North Shadeland Avenue just north of I-70 in Indianapolis. MACL is a high tech laboratory offering a full menu of laboratory testing including many esoteric and high complexity testing options to meet the needs of our clients. Ninety five percent of the testing you order is completed in our Regional laboratory. We are very proud of our facility and invite you to contact your sales representative to schedule a tour of the laboratory.

Our 75,000 square foot facility showcases our OLA (Olympus Laboratory Automation). This automated front end processing system is unique to MACL, as it is the only one in the state of Indiana. The OLA improves patient safety by eliminating human error for sample aliquoting and labeling; measuring the amount of specimen required by use of defined aliquot tube volume; and identifying sample integrity by detecting clots. The OLA improves turnaround times due to faster sorting of specimens to instruments for testing.

MACL also prides itself on having the largest Special Coagulation department in the state performing a multitude of esoteric tests daily. MACL’s Molecular Diagnostic Testing department uses the most up-to-date technology available. Both departments provide clients with cutting edge testing options to that provide information for better decision making in determining treatment options for patients.

MACL is a leading provider of clinical laboratory service in the central Indiana geography.

To schedule a personal tour, please contact your sales representative.

Mid America Clinical Laboratories will be changing the components of our stool culture to include testing to detect the presence of Shiga Toxin producing E. coli (STEC). The purpose of this initiative is to comply with strong recommendations from the Centers for Disease Control (CDC) that all laboratories routinely screen patients for infection by STEC as part of “routine” stool culture procedures. In two separate editions of Morbidity and Mortality Weekly Report (MMWR), the CDC has called for routine testing for these bacteria, when a clinician orders a “Stool Culture”.

The CDC is also requesting that E. coli O157 culture be performed on patients with positive toxin assays for the purpose of submitting the isolate via a public health laboratory to the CDC’s “Pulse Net” program which is designed to track outbreaks of food borne illness.

Therefore, effective June 7, 2010, order code 10045, Stool Culture (Salmonella, Shigella, Campylobacter only) will no longer be available. Order code 10045 will be replaced with order code 10108, Stool Culture (Salmonella, Shigella, Campylobacter and Shiga Toxin EIA with reflex to E. coli O157 culture) as our comprehensive “Stool Culture”. Orders for test 10045 placed after June 7, 2010 will be pointed to test code 10108.

Mid America Clinical Laboratories will be transitioning to a single, universal viral transport medium that will maintain the viability of Viruses, Chlamydiae, Mycoplasmas and Ureaplasmas. The green-top tube contains 3.0 ml of V-C-M (Viral-Chlamydia-Mycoplasma) medium and can be stored at room temperature prior to use. The single tube will streamline collection by replacing both the blue-top M4 and red-top M4RT transport media currently in use. Refer to the MACL Directory of Service for detailed instructions on storage and transport of specimens following collection.

Current Transport

Test Name Order Code

New transport

Blue-top M4 transport medium

· Culture, M. hominis and

Ureaplasma

871

Green top

V-C-M transport medium*

Red-top M4RT transport medium

· Culture, Herpes Simplex Virus Rapid

· Culture, Herpes Simplex Virus with typing

· Herpes Simplex Virus/Varicella Zoster Virus, Rapid Culture

· Culture, Viral Body Fluids

· Influenza A & B antigen detection

· RSV Antigen Detection

· Chlamydia trachomatis culture

2692

2649

17495

689

51029

51293

690

*V-C-M will most frequently be available in a green top tube; however, if the supply must be obtained through an alternate distributor, the medium may also be available in other colors and labeled as Universal Transport Medium for Viruses, Chlamydiae, Mycoplasmas and Ureaplasmas.

Test Code: 51375

Effective July 15, 2010, Mid America Clinical Laboratories began testing C. difficile by PCR using the Cepheid Xpert C. difficile real time PCR test rather than sending the testing to our reference laboratory.

Specimen information:

Specimen collection and transport: Stool specimens should be collected in a clean container with a secure lid (no preservatives), labeled, and sent to the laboratory on the same day as collection.

Specimens that are liquid or soft (i.e., takes the shape of the container) are acceptable.

Specimens that are formed or hard are not acceptable, unless ileus due to C. difficile is suspected. Patients may be colonized with toxin-producing C. difficile strains that are not causing active disease; therefore, it is not recommended that formed stool be tested.

Testing Schedule: Specimens will be tested at the Regional Laboratory 7 days a week. Results are available the same/next day.

Results and Interpretation: The real time PCR assay detects the toxin B gene. Reports will read as follows:

- Toxin producing C. difficile targets are detected.

- Toxin producing C. difficile targets are not detected.

More information:

There are a variety of tests available for the laboratory confirmation of C. difficile infection, or CDI (1-6). These are listed in Table 1. These tests include enzyme immunoassays (both solid phase and rapid immunochromatographic card tests); cell culture cytotoxicity neutralization assays; anaerobic culture; tests for glutamate dehydrogenase (GDH) antigen followed by a toxin test (two-step algorithm); and most recently, real time PCR testing. The sensitivities of these methods are quite variable (see Table 1) and can be as low as 33% especially when compared to anaerobic culture.

The molecular assay that will be in use at Mid America Clinical Laboratories is the Cepheid Xpert C. difficile real time PCR test. This test is a qualitative in vitro diagnostic for rapid detection of toxin B gene sequences from unformed stool specimens collected from patients suspected of having CDI. This test utilizes automated real-time polymerase chain reaction (PCR) to detect toxin gene sequences associated with toxin producing C. difficile. This assay is intended as an aid in the diagnosis of CDI. Concomitant culture is necessary only if further typing or organism recovery is required. This assay has been extensively evaluated in the literature and all reports confirm our findings of sensitivities ranging from 95% to 99%, depending upon the comparative methods.

Because of the enhanced sensitivity of PCR, duplicate/triplicate testing is not necessary nor is it recommended.

Table 1. Published Performance of Various C. difficile Testing Methods

Method	Sensitivity (%)	Specificity (%)
Enzyme Immunoassays and Rapid Card tests	33-90	83-100
Cell culture neutralization	65-80	97-98
Glutamate dehydrogenase (GDH) paired with toxin testing	55-85	96-98
Anaerobic toxigenic culture	90	96-97
Real time PCR	95.9-99.9	96.6-100

References:

Novak-Weekley SM, et al. J Clin Microbiol. 2010;48:889-893.
Sloan LM, et al. J Clin Microbiol. 2008;46:1996-2001.
Barbut F, et al. J Clin Microbiol. 2009;47:1276-1277.
Peterson LR, Robiscek A. Ann Intern Med. 2009;151:176-179.
Wilkins TD, Lyerly DM. J Clin Microbiol. 2003 Feb;41(2):531-4.
Delmee M. J Clin Microbiol Infect. 2001 Aug;7(8):411-6 Review

Greater than 50% of patients with rhinitis do not have allergic rhinitis. Non-sedating antihistamines don’t work for these patients.¹This allergy season consider an ImmunoCap Respiratory Allergy Profile. This FDA approved IgE blood test is simple and specific.

Rhinitis patients present with different symptoms. The challenge often is to differentiate between allergic and non-allergic rhinitis. ImmunoCap specific IgE blood testing in a primary care setting can improve diagnosis and management of patients with allergy-like symptoms. Upon clinical evaluation, ordering an ImmunoCap can assist in selecting a targeted treatment for allergic or non-allergic rhinitis based on interpretation of test results. If the patient is negative, or non-allergic, antibiotics, intranasal steroids, and decongestants may be the answer. On the other hand, if the patient is positive, allergen avoidance, antihistamines and appropriate referrals to a specialist are a more appropriate approach. Below is an algorithm that summarizes one approach to upper respiratory allergy patient management.

¹ Middleton E, et al, eds. Allergy Principles and Practice. Vol. 2,5^th ed. St. Louis: Mosby: 1998

As of September 1, 2010, Mid America Clinical Laboratories will begin reporting the Quantiferon ® -TB Gold qualitative and quantitative results. In “Updated Guidelines for Using Interferon Gamma Release Assays (IGRA) to Detect Mycobacterium tuberculosis Infection, United States,” published in Morbidity and Mortality Weekly Report, the CDC recommends:

§ IGRA testing may be used in place of (and not in addition to) tuberculin skin test (TST) in all situations in which CDC recommends TST as an aid to diagnosing M. tuberculosis infection.

§ IGRA testing is the preferred method for testing:

– Persons from groups that have historically poor TST return rate

– Persons who have received BCG

§ IGRA testing my be used in place of TST for:

– Contact tracing

– Serial and periodic TB screening

§ Due to insufficient evidence at the time of writing the guidelines, the CDC guidelines continue to recommend the TST in children aged less than 5 years. Other recommendations on IGRA testing in children are available from the American Academy of Pediatrics’ IGRA guidelines. (Please contact the laboratory for further information.)

§ Both qualitative and quantitative assay measurements should be reported.

The following interpretation criteria will be reported with each test ordered.

Interpretation	Nil (IU/ml)	TB Response (IU/ml)	Mitogen Response (IU/ml)
Positive	< 8.0	> 0.35 and > 25% of Nil	Any
Negative	< 8.0	< 0.35 or < 25% of Nil	> 0.5
Indeterminate 1	> 8.0	Any	Any
Indeterminate 2	< 8.0	< 0.35 or < 25% of Nil	< 0.5

Positive: Sample demonstrated an immune response to Mycobacterium tuberculosis antigens.

Negative: No immune response to Mycobacterium tuberculosis antigens was noted.

Indeterminate 1: A valid Quantiferon result cannot be reported due to elevated levels of interferon in the patient’s sample or a non-specific reaction with the test kit.

Indeterminate 2: A valid Quantiferon result cannot be reported due to insufficient immune response of the patient or questionable sample integrity.

Changes to the specimen collection will also occur at this time. As of September 1, 2010, all Quantiferon ®-TB Gold testing should be collected in the three tube collection system provided by Mid America Clinical Laboratories. The three tube collection system is known as the Quantiferon ®-TB Gold In-Tube (IT) system. The three tubes contain antigens that have been dried onto the inner wall of the blood collection tubes. These are the ONLY acceptable tubes that can be used for quantiferon testing due to the TB antigens added to these tubes. The tubes have a partial vacuum that will draw between 0.8 – 1.2 mL of blood. It is essential that vigorous shaking of the sample occur to mix the antigen dried on the side of the tube into the blood sample. The sample must reach the laboratory within 16 hours of collection. Specimens may be collected Monday – Friday. Green top tubes containing sodium or lithium heparin will no longer be acceptable by the laboratory as of September 30, 2010. Recollects will be requested for green top tubes after this date.

Mid America Clinical Laboratories is committed to providing our clients with the information they need to order medically appropriate testing for their patients. We are able to offer custom panels and custom critical ranges. If your practice consistently orders a battery of tests, it is possible to build a custom panel that contains each individual test. This allows for more simplified ordering and reduces the chance that a test is accidentally not ordered. This panel is only orderable by the members of the practice and is not available to other MACL clients. However, please keep in mind that you should order only those tests that are medically necessary for the diagnosis and treatment of your patients.

Custom critical ranges can be arranged for your practice as well. If there is a test that MACL does not deem a critical assay and it is pertinent for the care and treatment of your patient population, we can identify that assay and defined result ranges as critical for your practice. If MACL has a defined critical value range, and your practice would like to expand those parameters, we can customize that specifically for your practice.

For information on how to build custom panels or critical ranges, please contact your MACL sales representative

to initiate the process.

Mid America Clinical Laboratories (MACL) has recently updated CMS-R-131 (06/10) Advance Beneficiary Notice of Non-Coverage (ABN) form. Additional tests were added to make the form more complete. See list below.

208 Acid Phosphatase

237 Alpha Feto Protein Tumor Marker

852 Beta2- Microglobulin

4698 CA19-9

29493 CA27.29

36167 Collagen Cross Link

8396 HCG

10256 Hepatic Function Panel

8472 Hepatitis C Virus AB

31532 HPV, DNA (High Risk)

306 Ionized Calcium

7600 Lipid Panel

8847 PT with INR

35203 PTH Intact, IRMA

8837 PTH, Intact & Calcium

622 Serum Magnesium

799 RPR Monitor w/Refl

891 Transferrin

896 Triglycerides

899 TSH

36127 TSH w/Refl FT4

498 Viral Hepatitis Serology Testing

17306 Vitamin D Assay

The bullets below highlight changes that were made to the ABN in March, 2009. They are reprinted solely for a reminder.

The ABN may also be used for voluntary notifications, in place of the Notice of Exclusion of Medicare Benefits (NEMB).
The form has a mandatory field for cost estimates.

– If the test is currently listed on the ABN, please indicate test ordered by marking/checking the appropriate box.

– For tests not listed on the ABN, please check “OTHER”, fill in the name of the test and the estimated cost.

– The cost can be obtained by calling our Customer Response Center at 877-803-1010 and asking for the Patient List Price.

Option 2 gives the patient the option to choose to have services rendered and pay out-of-pocket instead of having a claim sent to Medicare.

Please ensure that an option is selected by marking/checking the appropriate box.

The patient name must be noted at the top of the ABN form.

Patient’s signature and date must be included at the bottom of the form.

The notifier’s name and contact number must be displayed in the top left hand corner of the form (Pre-printed with MACL information).

Please discard all previous laboratory ABN versions and begin using the new form.

The approved ABN form can be ordered through our supplies department. This is listed as an option on your client supply order form. If you utilize an EMR, please use the MACL paper ABN forms or the ABN generated from your EMR product. Care 360 users will have the form automatically updated.

If we can be of further assistance, please contact your MACL sales representative or the Customer Response Center at 877-803-1010.

Discount Laboratory Fees for Self-pay Patients

Mid America Clinical Laboratories is now offering discount laboratory fees for self-pay patients at all of our Patient Care Centers (PCCs). As part of this offering, we have implemented a full payment at time of service policy.

We will accept personal checks, Money Orders, Visa, MasterCard or American Express. For the safety of everyone, cash will not be accepted.

Please note that, although the policy is to require payment from uninsured patients PRIOR to collecting specimens, our intent is never to compromise patient care in the process. Extraordinary circumstances will always be considered.

New! Client Bill Online Invoicing

MACL is pleased to announce that through our affiliation with Quest Diagnostics we will soon be able to offer online client bill invoicing and payment processing. To enroll for this service or to view a demonstration, please visit our website at www.maclonline.com and click on the Pay Your Bill Quick Link on the left side of the homepage.

With this new service, you can:

· Access your statements and invoices anytime

· Perform quick audits

· Download invoices into your system through Excel

· Improve data management and analysis

· Reduce clerical handling and manual check processing

For additional information, please contact your MACL sales representative. Stay tuned for the go-live date to be announced.

	Test Code	Result (Reflex Criteria)	Second or Confirmatory Test	Test Code
AFB Culture	4554	All orders	AFB stain, due to need for rapid information	4503
AFB Stain	4503	All orders	AFB culture due to low sensitivity of AFB stain	4554
ANA Screen	249	1:80 or higher	ANA Titer & Pattern	36209
Anaerobic Culture	4469	All orders	Gram Stain	497
Anticardiolipin Antibodies IgA	4661	>22 or <40 APL	anti β2 Glycoprotein IgA	59309
Anticardiolipin Antibodies IgG	4662	>23 or <40 GPL	anti β2 Glycoprotein IgG & IgM	59310
Anticardiolipin Antibodies IgM	4663	>11 or <40 MPL	anti β2 Glycoprotein IgM & IgM	59310
Aspirated or deep wound specimen received for aerobic culture	4550	All orders	Anaerobic culture	4669
Bronchial Alveolar Lavage (BAL)	As Ordered	Any Specimen Submitted	Cytology	Not available as a separate test
Cryoglobulin	36562	Positive	Cryocrit (calculation)	Not available as a separate test
CSF, Deep Wound Respiratory Cultures	None 4550 SEE DOS	All orders	Gram stain due to CAP requirements	497
Culture	Various cultures	Pathogens isolated	Identifications and sensitivities for appropriate pathogens isolated	None
Culture, Fungus		All specimens	Fungal Smear
Dilute Russell Viper Venom Test (DRVVT)	59177	Abnormal	Dilute Russell Viper Venom Test ratio	59178
Gram Stain	497	CSF Specimen	Culture	4550
Hepatitis B Surface Antigen	8472	Positive	Confirmation	36204
Hepatitis C as part of a Needlestick Profile	None	Reactive with Low Signal/Cutoff Ratio	Hepatitis C Viral RNA Qual PCR	34024
HIV 1/2 Antibody Screen	19728	Positive	HIV 1 Western Blot if negative HIV 2 Western Blot	37651 38037
HIV 1/2 Antibody Screen	37694	Positive	HIV 1 Western Blot	37651
Homocysteine as part of a Thrombotic Profile	31789	>10.4	Methylene Tetrahydrofolate Reductase 677	36165
India Ink	59215	CSF Specimens	Fungus Culture	59250
Legionella Stain	None	All orders	Legionella culture, due to low sensitivity of Legionella stain	None
Mitochondrial Ab	259	Positive	Mitochondrial Ab Titer	36205
Platelet Function Adenosine Diphosphate (Within a Profile)	59180%	>115	Platelet aggregation	59154
Platelet Function Test, Epinephrine (PFT)	59149	>192 seconds	Platelet Function Adenosine Diphosphate	59180
Protein C Activity	1777	<70	Protein C Antigen	51019
Protein S Activity	1779	<50	Protein S Antigen and Free S Antigen	51023 51022
PTT Lupus Anticoagulant (Within a Profile)	59311	Greater than reference interval (>44.4 currently)	STACLOT™ LA	51027
PT Mixing Study or PT Differential	59161	MXPT >12.1 sec (corrects) MSPT >12.1 sec (not corrected)	Factor VII DRVVT	346, 59177
PTT Mixing Study or PTT Differential	59160	MXPTT >32.5 sec	Factors VIII, IX, XI, XII, DRVVT	347, 352, 360, 362, 59100
PT Mixing Study and PTT Mixing Study	59161 and 59160	MXPT >12.1 sec MSPTT >32.5 sec (not corrected)	Factors II, V, X, DRVVT	331, 344, 359, 59177
Rapid Group A Strep Screen	59360	Negative	Throat culture, due to low sensitivity of rapid test	394
RPR (Dx)	36125	Reactive	RPR Titer Treponema Pallidum Antibodies	36203 4112
RPR (Monitor)	799	Reactive	RPR Titer	36203
Semen Analysis	59151	No Sperm Seen	Fructose	59342
Stool for Ova and Parasites	681	All orders	Permanent stain (Trichrome)	Not available as a separate test
Teichoic Acid Antibody	36568	Positive	Teichoic Acid Antibody Titer	Not available as a separate test
Thrombin Clotting Time (Within a Profile)	883	>22.0	Thrombin Clotting Tim with Protamine Sulfate Correction	51014
Urinalysis	7909	Positive leukocyte esterase, nitrites, hemoglobin, protein or other than clear	Microscopic	8563
Urinalysis, Culture if indicated	3020	Nitrate positive or leukocyte esterase positive, WBC >5/hpf Bacteria > trace Yeast present	Urine Culture	395
von Willebrand Antigen (von Willebrand profile)	4919	<50	von Willebrand Multimers	5168
von Willebrand Activity	4459	<50%	von Willebrand Antigen	51024

Approved: __________________________________________

Terence J. Cudahy, M.D., Medical Director

Date: ___3/4/10__

*Be sure to read your Technical Bulletins throughout the year for

reflex test additions.

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