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ADVANTAGES OF GENE LEVEL DIAGNOSIS

RAPID DIAGNOSIS
Speed is especially important when hard to culture organisms are involved. With molecular based testing, results are available in as little as 24 hours as compared to 2-8 weeks for conventional testing methods. This will allow physicians to quickly identify an infection and treat it before it causes a life threatening disease.

EXTREME SENSITIVITY
Advanced molecular based testing encompasses a variety of DNA probe technologies. One such is the DNA amplification process known as PCR. This process greatly increases the number of copies of the target DNA, thus allowing for quantities as small as a single viral particle to be detected. Because of this, sensitivity is dramatically increased to levels unachievable with conventional detection methods.

DIRECT DETECTION
Conventional tests for viral infections, such as HIV, detect antibodies made against the virus, whereas genetic testing detects the actual virus. Thus, reliable positive or negative results can be given for the actual infection, independent of the antibody response.

STATUS MONITORING
Physicians can now monitor the efficacy of therapy and treatments initiated for patients (e.g., HIV-1 RNA Quantitation and HCV RNA Quantitation).

PREDICTIVE SCREENING
Using today's gene level diagnostic techniques, individuals with a strong family history of disease can actually be tested to determine if they carry the gene that predisposes them to developing the disease in question.

GENERAL SERVICES

STAFF EXPERTISE
The laboratory is directed by a board certified pathologist, John B. Thomison Jr., M.D., F.C.A.P. Laboratory activities are coordinated by Paul A. Dahlhauser, M.S., S.A. (Director of Laboratory Services) who is a board certified Special Analyst in Molecular Biology. The staff receives support and consultation from our highly qualified and diverse Board of Directors.

LICENSURE / REGISTRATION
The laboratory is licensed by the State of Tennessee, Office of Laboratory Licensing and Certification and has a Laboratory Registration Certificate from the Clinical Laboratory Improvement Amendments (CLIA). Applicable license and registration numbers are as follows:
State of TN, Lab License #: 0000003268
CLIA #: 44D0889747
Medicare Provider #: 3402805

QUALITY PROGRAMS
The laboratory participates in extensive internal and external proficiency testing, including that of the College of American Pathologists (CAP).

REPORTING RESULTS / DATA TRANSFER
Each report is faxed to the authorized client immediately, with an original report (hard copy) to follow by mail. Reporting times vary, depending on the nature of the request. Our goal is to assist physicians in identifying an infection and proceeding more rapidly, saving the patient valuable time.

CLIENT SERVICES / SUPPORT
GA's Client Services is committed to providing each client with the finest personalized service available to ensure all questions and concerns are met. Team members of our Client Services are readily available to discuss any of our services, tests, and results with our clients. Please call GA's Client Services at 615-781-0709 or 1-800-390-5280 Toll Free to request assistance, or visit our website at www.geneticassays.com.

AVAILABILITY OF SERVICE
Monday through Friday: 9:00 a.m.-5:00 p.m., CST

Our staff is dedicated to exceeding the needs of our clients and patients.

SPECIMEN HANDLING AND COLLECTION

SPECIMEN ACCEPTABILITY CRITERIA
Specimens must meet specifications set forth in this Directory. Specimens must be collected in appropriate sterile disposable containers. If applicable, the minimal acceptable volumes for each specimen is indicated within the "Test Directory" section.

SPECIMEN REJECTION CRITERIA
The best way to minimize specimen rejection is to clearly follow the specimen collection and submission requirements delineated in the "Test Directory" listing for each test.

If a specimen is received that is insufficient in quantity or quality, the original physician will be notified immediately that the chance of obtaining results is low. The physician has the option of submitting the specimen or collecting a new specimen.

SPECIMEN PICKUP
Specimen pickup is available at no charge for routine pickups prearranged with the laboratory. For specimen pickups please call 615-781-0709 or 1-800-390-5280.

As an additional service to you, Genetic Assays will provide your facility with the appropriate specimen submitting supplies. You are assigned a client number, which is preprinted on your Laboratory Request Forms, to assure correct reporting and billing.

To reorder supplies, please contact Client Services at (615) 781-0709, (615) 781-0766 FAX or
1-800-390-5280 Toll Free, or visit our website at www.geneticassays.com.

LABELING AND SHIPPING

General Information
Genetic Assays provides detailed specimen requirements for each assay in the Test Directory section of this Directory. The quality of laboratory results depends greatly on the proper collection and handling of the specimen. If temperature is not specified, then store and ship specimens at ambient temperature. Please note temperature ranges are as follows:

  • FROZEN specimens (dry ice) -20°C or colder
  • Cold pack (refrigerated) +2 to 8°C
  • Ambient +18 to 26°C

To insure the most rapid turn-around times and to preserve the integrity of the specimen, please follow the guidelines listed below. Please call Client Services at 615-781-0709 or 800-390-5280 if you have any questions regarding test ordering, specimen requirements, or supplies listed below.

Federal Regulations
U.S. Mail, Federal Express and Airborne Express regulations require specimen packaging to include the following:

  • watertight primary receptacle
  • watertight secondary packaging with biohazard labeling.
  • absorbent material (desiccant) place between the primary receptacle and
    secondary packaging.
  • sturdy outside packaging constructed of corrugated fiberboard (cardboard),
    wood, metal or plastic.

    Genetic Assays' specimen mailers meet these qualifications.

Overnight Transport
Ship by Federal Express. Please notify Genetic Assays laboratory at (615) 781-0709 or 800-390-5280 when a specimen is collected and delivery can be expected.

Specimen Labeling

  • use patient's full name
  • sending Lab's Patient I.D. number (same as indicated on the Lab Request Form)
  • date and time specimen collected
  • type of specimen (source)

Laboratory Request Form
A separate Laboratory Request Form should be included for each patient; please type or print clearly. Genetic Assays can provide pre-printed customized Laboratory Request Forms. Please call Client Services to open a new account or to order Laboratory Request Forms.

Please include the following information when completing a Laboratory Request Form:

  • name and address of sending Laboratory / Client
  • ordering Physician with UPIN number
  • sending Lab's account number with Genetic Assays
  • required patient demographic ( patient name, sex, date of birth, specimen ID
    number), billing and clinical information
  • Genetic Assays test code with full name of requested test

BILLING OPTIONS

Genetic Assays offers several billing options to our clients. We offer the flexibility and convenience of filing using any of the following options to best meet your needs:

  • Client billing: billing to group practice, health care provider and/or physician
  • Patient billing: billing the patient directly
  • Third-party-payer billing: billing to insurers with whom Genetic Assays, Inc.
    has a claims processing agreement
  • Medicare: Genetic Assays will bill Medicare and accept assignment.

CLIENT BILLING

Client billing accounts will receive an itemized statement for Genetic Assays' services once each month. Payment of the statement is due upon receipt. Should you have any questions or feel your statement is in error, please contact us immediately to prevent any delays in adjustments or payments. Please include your client number on all correspondence and payments.

PATIENT BILLING

If local or state requirements preclude providing the patient's name to ensure confidentiality, we will be unable to provide patient billing. If you elect to have your patients billed by Genetic Assays, the patient's name, address, and telephone number must be included on the Laboratory Request Form. An insurance copy is included with each initial bill to assist the patient when submitting a claim for Genetic Assays' services to an insurance company. The insurance company should pay the patient directly. The patient is solely responsible for the charges. Patient bills are due upon receipt.

On Genetic Assays' Laboratory Request Form please include:

  • Patient's full name
  • Patient's current address with apartment number and zip code
  • Patient's current phone number with area code
  • Guardian's (responsible party's) full name, address, and phone number

    THIRD-PARTY-PAYER BILLING

If local or state requirements preclude providing the patient's name to ensure confidentiality, we will be unable to provide third-party-payer billing. This option allows for billing to third-party-insurers with whom Genetic Assays has a claims processing agreement. For private insurers, please contact the billing department to ensure that Genetic Assays has a claims processing
agreement with them. Patients will be responsible for such charges as non-covered services, co-insurance charges, and deductible amounts depending on the type of coverage they have.

Genetic Assays will bill the patient's insurance company if the following information is provided:

  • Patient's full name
  • Patient's full address
  • Guarantor's (insured) name (if different from patient)
  • Insurance company complete name and address
  • Guarantor's (insured) group number
  • Guarantor's (insured) policy number
  • Proper ICD-9-CM diagnosis codes

MEDICARE

If your patient has Medicare coverage, please send us complete information. Genetic Assays will bill Medicare and accept assignment. Complete information must be entered on Genetic Assays' Laboratory Request Form at the time the specimen is submitted. Genetic Assays Medicare provider number is 3402805 Please provide:

  • Patient's full name (as it appears on the card)
  • Patient's current address with apartment number and zip code
  • Patient's current phone number with area code
  • Patient's gender
  • Patient's date of birth
  • Medicare HIC # (9 numerics + 1 alpha suffix)
  • Diagnosis (ICD-9-CM code)
  • Referring physician's name (first and last)
  • Referring physician's UPIN (5 digits with alpha prefix)*
    *This number must be included on Genetic Assays Lab Request Form at time of service.

If you have billing questions, contact the billing department at (615) 851-6875.

CURRENT PROCEDURAL TERMINOLOGY (CPT) CODES

CPT codes provided in this Directory are provided only as guidance to assist you in billing. The CPT codes listed reflect our interpretation of CPT coding requirements only and are subject to change at any time. It is your responsibility to verify the accuracy of the codes listed and to assign values to each code based on the reimbursement for your area.

If you have any questions, please refer to your CPT manual published by the American Medical Association. To verify reimbursement, or if you have questions regarding usage of a CPT code, please contact your local Medicare carrier.


CHANGES IN METHODOLOGIES AND FEES
As scientific advances occur, Genetic Assays may deem it necessary to add or change test methodologies or components. Methodologies and fees are subject to change without prior notification. Genetic Assays will continue to do its best to inform clients of any changes, particularly with regard to reference range changes.