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SLCH Clinical Laboratory Policies

 
POLICY STATEMENT FROM MAYO MEDICAL LABORATORIES ABOUT ANALYTE-SPECIFIC REAGENTS (ASR): 
Mayo Medical Laboratories:
The ordering of tests which utilize ASRs is limited to physicians and other persons authorized by applicable state law to order such tests. As required by the Food and Drug Administration, HHS, the following comment will appear on the test report when ASRs are utilized to perform the test:  “This test was developed and its performance characteristics determined by Laboratory Medicine and Pathology, Mayo Clinic Rochester. It has not been cleared or approved by the U.S. Food and Drug Administration.” 

POLICY STATEMENT FROM ST. LOUIS CHILDREN'S HOSPITAL ABOUT ANALYTE-SPECIFIC REAGENTS (ASR): 
St. Louis Children’s Hospital Clinical Laboratory:
As required by the Food and Drug Administration, HHS, the following comment will appear on the test report when ASRs are utilized to perform the test: “This test was developed and its performance characteristics determined by St. Louis Children’s Hospital Clinical Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration.” 

Animal Specimens
We do not accept animal specimens for laboratory testing except by special arrangement with the appropriate Laboratory Director or Supervisor approval.

Cancellation of Tests
Cancellations received prior to testing will be honored at no charge.

Confidentiality of Results
St. Louis Children’s Hospital Laboratory is dedicated to providing quality healthcare services to our patients.  By following laws, regulations and ethical obligations, we earn the trust and respect of our patients and our community.  We respect the confidentiality of our Patient's health information.  We have policies and guidelines in place to ensure that laboratory results are being released within the requirements of the law. We appreciate your assistance in helping St. Louis Children's Hospital Laboratory preserve patient confidentiality.  When requesting the release of patient results the provision of appropriate identifiers will greatly assist in a prompt and accurate response.

CPT Coding
It is your responsibility to determine the correct CPT codes to use for billing. While this catalog lists CPT codes in an effort to provide some guidance, the CPT codes listed reflect only our interpretation of CPT coding requirements and may not necessarily be correct. Particularly, in the case of a test involving several component tests, this catalog attempts to provide a comprehensive list of the CPT codes for all of the possible components of the test. Only a subset of the component tests may be performed on your specimen. You should verify the accuracy of the codes listed; and where multiple codes are listed, you should select the codes for the tests actually performed on your specimen.  ST. LOUIS CHILDREN’S HOSPITAL (SLCH) ASSUMES NO RESPONSIBILITY FOR BILLING ERRORS DUE TO RELIANCE ON THE CPT CODES LISTED IN THIS CATALOG.  For further reference, please consult the CPT Coding Manual published by the American Medical Association; and if you have any questions regarding the use of a code, please contact the party being paid.
 

St. Louis Children's Hospital uses Mayo Medical Laboratories (MML) for certain reference testing services.  Many of the laboratory tests, panels, and profiles that MML performs for St. Louis Children's Hospital Laboratory are identified and listed in this test catalog.  The MML tests, panels, and profiles have been established by MML in accordance with their policies and procedures.  Any listed MML profile that contains multiple CPT codes should be treated as a profile for purposes of Medicare.  Therefore, the ordering physician should order the profile only if all of its components are medically necessary for the particular patient.  If all of the components are not medically necessary, the physician should order only the necessary tests.  For further reference, please consult the CPT Coding Manual published by the American Medical Association; and if you have any questions regarding the use of a code, please contact your local Medicare carrier. 

Specimen Labeling Requirements
All specimens submitted to the St. Louis Children's Hospital Laboratory for analysis must follow the collection process for identification of the patient and be properly labeled. 

Specimens are considered properly collected according to the following criteria:
1. Specimens are labeled at the point of collection.  This must be done by the person obtaining the specimen.
2. The unique identifiers obtained from the patient must match those on the requisition and the specimen label.

Specimens are considered properly labeled according to the following criteria:
1. Specimens are labeled with the patient's first and last name and another unique patient identifier :  
    (i.e.   Medical record number, Date of birth, Social security number, Financial number)
2. Specimens for trauma patients may be labeled with an alpha numeric identifier and do not require a 
    second unique identifier.  Patient identification for trauma patients shall remain unchanged for the first 
    24 hours of the patient’s admission.            
3. Blood Bank specimens require the above information as well as date of collection, and initials or signature of the individual drawing
    the specimen.  Specimens with trauma number designations may only be used for compatibility testing for 24 hours provided the requests for
    transfusion use the Trauma Number.  After 24 hours, a new specimen shall be collected for compatibility testing upon updating the patient’s
    demographics. Each separate tube or container collected must have its own label affixed to the specimen.
4. Specimens will be considered unlabeled or mislabeled and not acceptable for analysis if any label requirements are missing, illegible, or
    inaccurate.
5. Each separate tube or container collected must have it's own label affixed to the specimen (one label around two tubes is not acceptable).

Specimens must also be sealed and properly contained.  Examples of specimens not properly contained:
Leaky urines
Tubes of blood not sealed correctly
Any other body fluid not contained properly 

IMPROPERLY LABELED SPECIMENS SUBMITTED FOR ANALYSIS
Specimens will be considered unlabeled or mislabeled and not acceptable for analysis if:
There is no label on the specimen.
1. The patient's name and/ or unique identifier (Medical record number, financial number, Date of Birth, social security number) is missing from the specimen container.
2. The unique identifiers on the labeled specimen do not match the unique identifier of the labels in the biohazard specimen bag.
 

Requisition Requirements
Testing orders should be requested on a St. Louis Children’s Hospital requisition.  Providing complete information on each laboratory requisition is necessary to ensure accurate ordering, timely reporting and correct billing.  The following information is required on the requisition:

Complete patient information - Patient's first and last name, sex, date of birth and social security number.
Ordering physician - First and last name.
Tests or assays requested - clearly marked.
Source of the specimen - when applicable.
Clinical information - when applicable.
Billing instructions - indicate how patient is to be billed.
 

When a third party is to be billed the following additional information is necessary.
Patient's complete address, diagnosis, commercial insurance plan name and address, name of subscriber and certificate and group numbers.
Note: A photocopy of both sides of the patient's insurance card attached to the requisition is sufficient for the required insurance information.

Supplies
Mailing cartons, specimen vials, special specimen collection containers and kits, sterile vials, stool containers, and request forms are supplied without charge.  Contact Laboratory Customer Service at (314) 454-4161. 

Specimen Rejection
All tests are unique in their collection and testing requirements. To avoid specimen rejection or delayed turnaround times, please check the “Specimen Required” field within each test. You will be notified of rejected or problem specimens upon receipt. 

Please review the following conditions prior to submitting a specimen to St. Louis Children’s Hospital:
Any timed urine collections (e.g. 12 hour, 24 hour, etc.)
pH of urine
Lack of hemolysis/lipemia
Specimen type (plasma, serum, whole blood, etc.)
Specimen volume
Patient information requested
Patient/specimen properly identified
Specimen container (metal-free, separation gel, appropriate preservative, etc.)
Transport medium
Temperature (ambient, frozen, refrigerated)

 
Reference Lab Testing
The main reference laboratory used by St. Louis Children's Hospital is Mayo Medical Laboratories. 

November 2012