Laboratory professionals will be celebrating National Medical Laboratory Week April 2-8, 2000.  The slogan this year will be Laboratory Professionals Guiding Healthcare into the New Millennium.  Laboratories around the network will be planning events to celebrate the profession.

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The Avera Laboratory Network launched its website in December of 1999.  Our address is www.averalabnet.com.  The site includes links to professional organizations and government agencies of interest to our laboratory family.  There is an anonymous survey to let us know if we're meeting your needs.  Past issues of Labnews are available as well.  In the future an on-line catalog of laboratory services will be available.  Check us out!

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On November 2, 1999 the Food and Drug Administration announced that Abbott Laboratories had signed a consent decree of permanent injunction.  In the agreement, Abbott agreed to stop manufacturing and distributing many of its in-vitro diagnostic tests until it corrects manufacturing problems in its Diagnostics Division.  Over the past six years, Abbott has failed to comply with FDA's Good Manufacturing Practice and Quality System regulations.  Abbott has failed to correct its problems, despite warnings from the FDA.

According to Jane E. Henney, MD, Commissioner of Food and Drugs, "These violations do not necessarily mean that Abbott's diagnostic products will harm patients, but the firm's failure to follow good manufacturing requirements decreases the level of assurance."  FDA is not recommending that diagnostic tests be repeated for those patients whose initial testing was done with Abbott's in-vitro test kits.

Manufacturing practices at Abbott first raised FDA concerns in 1993, when deficiencies were found during FDA inspections of the firm's Abbott Park, Ill. and North Chicago, Ill. manufacturing facilities.  Violations were in process validation, production and process control, and corrective and preventive action.  After these inspections, FDA sent a warning letter to Abbott in March 1994.  Subsequent FDA inspections during 1995, 1996, 1997 and 1998 continued to find the same types of deficiencies.  FDA efforts to work with Abbott to correct these problems were unsuccessful causing FDA to send another warning letter in March 1999.  Re-inspections in May, June and July 1999 found continuing deficiencies.  FDA then sought a court order to ensure that the firm's processes were brought into compliance in a timely manner.

Under the consent decree, FDA will allow the firm to continue distributing certain medically necessary tests for screening blood donors for infectious blood-borne disease.  FDA already subjects such tests to lot -- release as an additional control, and there is no evidence that they have been ineffective.  All other Abbott diagnostic devices will remain available for 30 days to permit users to standardize and obtain other test methods.  FDA recommends the use of additional quality control material made by other companies to increase the assurance of successful performance of Abbott tests.  After 30 days from the effective date, Abbott will no longer be permitted to manufacture or distribute non-medically necessary tests.

Abbott has agreed to correct deficiencies in its manufacturing processes as quickly as possible.  An outside expert, hired by Abbott, will certify to FDA that corrections have been made.  FDA will reinspect Abbott facilities to verify that the products have been validated and the processes conform to the Quality System Regulation.

The laboratories of the Avera Laboratory Network have contingency plans for the unavailability of Abbott products.  When current stocks of reagents and kits are gone, transitions will be made to products from other manufacturers.  This may mean method changes for some tests.  In some cases, testing will be sent to outside reference labs if in-house changes aren't possible.

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SUBJECT:  Blood Counts

Description:  Blood counts are used to evaluate diseases such as anemia, leukemia, reaction to inflammation and infections, polycythemia, hemolytic disease of the newborn, and to monitor treatment effect with some high-risk drugs.  The complete blood count (CBC) commonly includes WBC, Hct, Hgb, platelet count, RBC count, RDW count, WBC and RBC morphology, WBC differential count, and histograms.

A complete blood count is generally performed with automated equipment.  Calculated values such as mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC) are frequently included in a CBC.

A CBC and leukocyte differential count are two of the most common laboratory test obtained in medical practice.  Medical review of claims and physician documentation demonstrates widespread use as screening.

Indications & Limitations of Coverage and/or Medical Necessity:

1. Indications for performing the CBC generally include anemia for which no cause is apparent, or the evaluation of marrow function.
2. Specific indications for hematocrit and hemoglobin include signs/symptoms, test results, illness or disease that can be associated with anemia.
3. Indications for WBC with or without differential count include fever, leukemia, infections or inflammatory processes.
4. Indications for the platelet count include unexplained bleeding, ecchymosis, purpura, high-risks drugs, etc.
5. Blood counts are almost routinely ordered whether a clinically relevant disease is present or not.  Under the Medicare program, tests may be reimbursed only when current or suspected disease state is present.  Routine and screening testing is not reimbursable.
6. Absence of physician documentation which supports medical necessity for the tests will result in denial of payment by Medicare.

Currently, this policy does not differentiate between those disease categories appropriate to red blood cells, white blood cells, platelet counts, etc.  It is expected that the physician will order only the specific test relating to the problem present.  To order a CBC when only hemoglobin or a WBC count is needed is improper.  Post pay monitoring will be performed to ensure appropriateness of testing.

Reasons for Denial:

1. Medicare does not pay for manual or automated percentage, ratios, or calculations.
2. Routine or screening tests performed in the absence of signs, symptoms, or personal history of disease are statutorily excluded from coverage.
3. Any tests not medically reasonable and necessary for the diagnosis and treatment of an illness or injury are not covered.

Non-covered ICD-9 codes:  Any ICD-9 code not listed in the "Covered ICD-9 diagnosis" of the model policy.

Documentation Requirements:

Documentation supporting the medical necessity of any testing must be submitted on the claims.  Failure to do so may result in denial of claims.  The ordering physician should retain in the patient's medical record, history and physical, examination notes documenting evaluation and management of one of the Medicare covered conditions/diagnosis, with relevant clinical signs/symptoms or abnormal laboratory test results.  The medical record should also indicate changes in medications prescribed for the treatment of these conditions.  There must be a documented physician's order for each test in the medical record.  Documentation must be supplied to Medicare on request.

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Effective January 1, 2000, Avera McKennan will change methodology for evaluation and cold agglutinins.  EDTA whole blood will no longer be acceptable specimen.  The new specimen requirement is serum.  One red top (clot) tube is collected and kept at 37 C until the specimen is clotted, been centrifuged and serum separated into a transport tube.  One ml of serum is then transported at 2-8 C.  Do not refrigerate the specimen prior to processing.  Refrigeration before separation of serum from cells will adversely affect test results.

The reference range for this hemagglutination test is < 1:32.  Titers of 1:32 or higher are considered elevated by this technique.  Elevated titers are rarely seen except in primary atypical pneumonia and in certain hemolytic anemias.  Mycoplasma pneumoniae, influenza A, influenza B, para influenza, and adenoviruses can cause primary atypical pneumonia.  A four fold rise in the cold agglutinins usually begins to appear late in the first week or during the second week of the disease and begins to decrease between the fourth and sixth week.

Low titers of cold agglutinins have been demonstrated in malaria, peripheral vascular disease, and common respiratory disease.

A more specific diagnosis test is available for antibodies to Mycoplasma pneumoniae.  It is suggested that this test be ordered if Mycoplasma pneumonia is suspected.

Contact the client services department at Avera McKennan Regional Laboratory for more information.

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ICD-9 CODING TIPS

• Stay up-to-date on your carrier's local medical review policies.  This will provide specific information about when and how Medicare will pay for a lab test, and the diagnosis codes that are considered reasonable and necessary.  Usually the carrier will list ICD-9 codes needed on a claim in order for it to be paid.  Make sure to subscribe to your carrier's monthly Medicare bulletin, and put the lab on the list to see it.  Carrier's websites may have some post payment policies, although these may not be updated as frequently as they should.
• In your compliance plan, specify that there must be documentation from the physician in the patient's record to support lab test orders.
• The Balanced Budget Act of 1997 (pub. Law 105-33) says physicians must report ICD-9 codes to the highest level of specificity.  That means:
  • Listing the diagnosis code for the condition or reason for the patient's visit.
  • Only use three-digit codes hen there are no four or five-digit codes within a category.
  • Code signs, symptoms or abnormal test results rather than using "rule out" "probable" or "suspected" diagnosis.
  • Report chronic disease treated on a regular basis.  Be as specific as possible in coding and be sure that chronic conditions are documented in the patient's chart.
  • For preoperative testing, first use the V code for surgery, then code the reason for surgery.  Clinics often have trouble getting paid for hospitals' required pre-op testing because Medicare considers the tests non-covered screening tests.  In these cases, it's probably better to refer the tests to the treating hospital.

What not to do:

• Don't use diagnostic information from earlier dates of service;
• Don't create diagnosis information just because it got claims paid the last time;
• Don't use computer programs that automatically insert a diagnosis code, even when there's no supporting documentation for it; and
• Don't give the physician a "multiple choice" list of diagnosis codes to choose from.

Diagnosis coding strategies for your doctors.

• Track physician's compliance and give them feedback.
• Put a check box on your requisition form to indicate that the physician has signed ABN from the patient for tests that may not be covered by Medicare.
• Constantly remind physicians.
• Create physician-friendly requisition forms.

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FROM THE EDITOR...