Laboratory Services at SSM Health St. Mary's Hospital - Madison

Our messenger service picks up specimens and delivers results Monday through Friday for lab services clients. Routine Saturday pickup is available on a limited basis. Although our laboratory is open, the messenger service is not available on the following holidays: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving and Christmas.

The majority of supplies required for collection and transport of samples which will be tested at lab services are provided to clients without charge. A supply ordering form is provided to assist in filling your order promptly. If supplies other than those on the order form are required, please call the office staff to help facilitate your request. Please allow one week (five business days) for the preparation and delivery of these supplies and requisition forms.

This manual lists the days on which each test is set up and the time you can expect results available after each run. Preliminary test results are available for most of the tests which require several days to complete. Results will be phoned to you or the physician directly if you indicate a phone number and name of a contact on the order requisition. If you request a result to be called after your usual office or laboratory hours, please provide the phone number where the physician can be reached on evenings or weekends.

An extensive quality control program and follow-up on all suspected erroneous results are an integral part of the quality of service we provide. We will repeat, at no charge, any test where our initial results are incompatible with the physician's clinical findings. Specimens are held for seven days after being tested. Any request received during that time will be done on the original specimen provided the component in question is stable and the necessary volume is available. If not, a repeat will be done on a newly submitted sample.

A client may prefer to have a patient's specimen collected at our laboratory directly. Arrangements for this service can be scheduled by calling our office between the hours of 8 am and 4:30 pm. Please instruct patients to come to the laboratory directly; patient registration is not necessary, however there is a fee for collection which is listed in your fee schedule.

Associated Pathologists, SC, are available for test result interpretation or consultation. In addition, we have a fully qualified staff of experienced technical personnel who are available to provide assistance. Our Technical Representatives can also be used to arrange any special consultation services for you.

Technical representatives are available to work with you in your laboratory as needed. We can offer assistance in resolving technical problems, evaluating equipment needs, delivery or billing problems or daily quality control issues. Appropriate assistance can be arranged by calling our Customer Services Assistants at 608-258-6917.

The laboratory staff would be happy to have you visit our facilities at any time. Such visits provide the opportunity to exchange information on testing, equipment, methodologies and policies, as well as seeing first-hand the quality of service we provide. It also provides an opportunity for us to learn more about your facility and expectations.

With very few exceptions, our laboratories working in conjunction with each other can provide the full range of services to meet the needs of your patients and physicians -- your laboratory as the primary laboratory service, SSM Health St. Mary's Lab Services as the secondary reference lab and other contracted reference laboratories as the tertiary service for both of our facilities. Occasionally lab services uses services of other reference laboratories for very specific tests; in those cases specimens you refer to us will be sent there. We only refer specimens to accredited reference laboratories meeting our specifications.

When requesting tests which will be referred on to a tertiary reference lab, please use the Clinical Laboratory Referral Test requisition provided. If a test is not listed, please print the appropriate test name and test code on the requisition when available. The name of the laboratory performing the test will be included with the report.

Our fee schedule is published separately on an annual cycle and is available through the office. A contract billing summary and detailed invoice, issued the first week of every month, covers those test procedures requested during the previous calendar month. All payments are due 45 days from the date of the related invoice and are independent of any reimbursement received by the client from patients or third-party payers. Questions regarding clarification on any invoice should be directed to the office staff.

• Consistent with federal regulations, charges for tests you have referred on Medicare or Medicaid patients will be billed directly to the carrier by SSM Health St. Mary's Hospital - Madison. Appropriate Medicare/Medicaid numbers and ICD-9 codes must be included at the time the test is ordered.
• Each individual component of any panel must be medically necessary to qualify for reimbursement. Medicare will not pay for non FDA-approved tests or for screening tests.
• If there is a reason to believe that Medicare will not pay for a test, the patient should be informed of that fact. The patient should then sign an Advance Beneficiary Notice (ABN), to indicate that he or she is responsible for the test if Medicare denies payment.
• If no ABN was received with the specimen before processing or there was inadequate documentation and payment was denied by the fiscal intermediary, lab services will bill the client for the services that were provided.
• The client accepts financial responsibility for any test ordered where insufficient diagnosis information has been given and/or are considered not medically necessary according to Medicare or Medicaid.
• In the event a client discovers that the patient is actually a Medicare patient after a test was submitted and completed, the client will be allowed a 45-day grace period after the receipt of the invoice to provide appropriate Medicare information for lab services to bill Medicare appropriately. The client account will be credited for the initial charge. The client will be responsible to pay lab services for any test for which information received exceeds the 45-day grace period.
• If these lab orders are being done in conjunction with an inpatient hospital stay at the same time of order or planned within the next 72 hours, billing must be included in the DRG billing done at the hospital where the patient is/or will be.

If the patient's primary insurance coverage for laboratory services is Medicaid, lab services will invoice Medicaid directly. The client is not responsible for payment of covered services under Medicaid when it is the primary insurance.

An order requisition must accompany each specimen or group of specimens. SSM Health St. Mary's Hospital – Madison Laboratory Services provides four types of order requisition, (1) clinical laboratory, (2) surgical pathology, (3) microbiology, and (4) frequently ordered tests that are sent to another reference laboratory. Order requisitions are pre-printed with client name and account number for your convenience. For accuracy in testing, reporting and billing, please print clearly or type all patient information requested. Minimum patient information required for accurate result interpretation includes the patient's full "legal" name (First and Last), date of birth and sex, as reference ranges are age and sex dependent. If a clinic record or patient identification number is necessary for proper distribution of reports in your office, please include it in the patient number or lab number area on the order requisition. Your number will be transferred to the patient's report and will appear on the result copy headers of the report. The originator's copy is provided as a record for you to verify orders and monthly invoices.

SSM Health St. Mary's Laboratory Services participates in the Medicare/Medicaid programs and accepts assignment for patients covered by these programs in accordance with current regulations. When referring tests on patients covered by one of these programs, additional patient information is required to process the bill directly: Patient's address, Medicare or Medicaid number, ICD-9 Code(s), and supplemental insurance information. This information must be supplied at the time the test is ordered. SSM Health St. Mary's Laboratory Services relies on the ordering physician to notify and educate Medicare patients when the tests they are ordering are not covered by Medicare as being medically necessary. The ordering facility is required to obtain a government approved Advanced Beneficiary Notice (ABN), indicating the patient is aware of his/her responsibility to pay for non-covered service. One copy of the signed ABN should be sent with the specimen, one given to the patient and one maintained at the ordering facility.

A miscellaneous area for ordering tests which do not appear on the requisition is provided for additional tests, specimen or patient information.

Multiple Tests

When multiple tests requiring different processing are requested on the same patient, please identify the specimen type on the transport tube. Be as specific as you can be, especially since many different types of plasmas are now tested, i.e.: EDTA plasma (for cardiac marker), citrate plasma (for coagulation) and heparinized plasma for CKMB. If a single sample tube needs multiple tests done on it, please do not freeze unless you first aliquot to separate tubes.

As methodology or instrumentation changes in our laboratory, our reference ranges also may change. The ranges listed in this manual reflect adult values for current methodology unless indicated. Age specific reference ranges for neonates, pediatrics and adolescents are included in addendum #5. It is important to refer to the reference range printed on the patient's result copy as this will always reflect the correct normal value for the methodology currently in use, the age, and sex of the patient.

Most frequently ordered tests are reported within 24 hours following receipt of the specimen at SSM Health St. Mary's. Those which require a longer processing time will be reported as soon as they are completed. This manual lists the days on which each test is set up as a guide to the expected turnaround time.

SSM Health St. Mary's Laboratory Services' computerized reporting system includes a chart-ready report form with reference ranges for the age and sex of the patient. Abnormal results are identified with an "H", "L", or "P" following the patient value indicating a result higher or lower than the expected reference range, or that the value is a "panic or life threatening" value. A panic laboratory value is a value at such variance with normal that it represents a pathophysiologic state which is life-threatening and requires immediate and appropriate medical action. Our laboratory staff communicates each and every panic value immediately to the client, ordering physician or his/her nurse. If you receive such a call, please forward the information to the physician immediately.

If you need results before your next scheduled printing or delivery, we will be happy to fax your results. Please supply the fax numbers. If results are needed after your usual hours, please provide a phone number where the physician can be reached.

Preliminary results will be reported for tests which require a lengthy time to process, such as cultures; positive cultures will be phoned.

Proper identification of samples is the responsibility of the client. Each specimen should be clearly and legibly labeled with the following information (a typed label is preferred):

• Patient’s first and last (legal) name
• Date of birth
• Client name
• Tests ordered
• Collection date and time
• Specimen type (serum or plasma)

Some specimens cannot be analyzed because of improper collection, identification or storage. Our laboratory does not accept or test unlabeled or mislabeled specimens for venous blood, stool, or urine. You will be notified of any specimen problem on receipt. Notification of any corrective action taken will be documented for you on the report.

The following is a checklist you should confirm before referring any specimen:

• Patient/specimen identified properly
• Correct specimen type
• Adequate specimen volume
• Appropriate transportation medium or container
• Specimen label is attached and correct
• Lack of hemolysis
• All requested patient information is included
• Medicare information, if applicable
• ICD-9 diagnosis code(s) included

To ensure the most accurate and reliable results, it is imperative that all specimens are properly collected, separated and stored at the proper temperature prior to pick up. Specimen requirements and volumes required are included with each procedure, with special handling instructions appearing in bold print. Refrigerate all specimens until pick up unless otherwise indicated.

Frozen Specimens

Frozen specimens will be transported on dry ice. If multiple tests are ordered and one or more are required to be frozen, please aliquot the specimen in the appropriate quantity for each test before freezing.

Fasting Specimens

Certain tests are most accurate if performed when the patient has been fasting. Instruction to the patient should include avoiding intake of all food and beverages except water for 12 hours prior to the time the specimen will be collected.

The type of specimen and collection code appear with the specimen requirement for each test as indicated below: (When multiple tests are drawn, please draw in the same order listed.)
 

1. General Precautions
   Extraordinary care must be taken to avoid accidental wounds from sharp instruments contaminated with potentially infectious material and to avoid contact of an open skin lesion with material from these patients.
2. Handling
   Disposable gloves should be worn when handling blood specimens, blood soiled items, body fluids, excretions and secretions as well as surfaces, material and objects exposed to them. Hands should be washed after removal of disposable gloves.
3. All specimen tubes should be spun with the cork in position in a sealed container to guard against aerosol formation each time the specimen is spun. Transfer of specimens should be done with DispoPipettes – no mouth pipetting.
4. Specimen Handling
   After proper collection and processing, each specimen should be put in a zip lock transport bag with the requisition folded and put in the outside pocket of the bag with the patient's name facing out.
5. Transportation
   All couriers must comply with Federal Regulations which specify how specimens must be packaged for transport. Couriers may not transport improperly packaged specimens. Couriers will refuse to transport specimens which are not correctly packaged at time of pickup.
   1. Personnel other than an SSM Health St. Mary's Hospital - Madison lab services messenger (cab, physician, client employee, volunteer) Transportation via cab.
      1. Place specimen in a plastic container with a leak proof cap.
      2. Place plastic container in a zip top plastic bag with a biohazard label. (If needed, place ice inside the bag also, taking care not to overfill it.) Ensure that the bag is securely closed.
      3. Place bagged specimen in a rigid container, such as a Styrofoam box or plastic specimen container ("cottage cheese" type) and seal.
      4. If desired, place inside a brown paper bag for ease of carrying. The outer most container (brown bag or rigid container if paper bag not used) must have a label identifying the contents:
         1. If a biological specimen, use biohazard symbol
         2. If a pathology specimen in formalin, use formaldehyde warning label
   2. US Mail (primarily tissue specimens) - The US Postal Service requires the following packaging:
      1. Place specimen in a plastic pre-filled formalin container with a leak proof cap. Note warning label and handle with care.
      2. Label specimen container with patient name and type/site of tissue. Wrap container in sufficient absorbent material to completely absorb the contents in case of leakage.
      3. Place wrapped plastic container in a zip top plastic bag. Ensure that bag is securely closed. Paperwork should be placed in the outer pocket of the bag.
      4. Place bagged specimen in a Styrofoam box and seal with tape.
      5. Place Styrofoam box inside addressed cardboard mailing sleeve. The outside mailing box must be labeled with a formaldehyde warning.
   3. Overnight Courier (primarily flow cytometry specimens)
      1. Fresh tissue specimens must be shipped by overnight courier.
      2. Place fresh tissue specimens in a plastic container with a leak proof cap. The container must contain tissue culture media (RPMI 1640 or similar media), in order to retain the specimen integrity. Media is available upon request. Make sure that the volume of media is at least twice the volume of the tissue. Place container in a zip top plastic bag.
      3. If specimen is whole blood or bone marrow, place the container in a zip top plastic bag. Ensure that the bag is securely closed.
      4. Place the bagged specimen and enough absorbent material to absorb the liquid in the container. Place paperwork in a mailing cylinder or box, and seal it with tape.
      5. Place the overnight courier label and a biohazard label on the outermost container.
      6. Call the flow cytometry lab (608-258-6309) and inform them the specimen will arrive the next day. This will ensure that the specimen is processed as soon as it arrives.
      7. During excessively cold weather conditions, please contact the flow cytometry lab for further instructions. ***

Any and all resident records, charts or reports produced by SSM Health St. Mary's Hospital – Madison laboratory services are and remain the property of SSM Health St. Mary's Hospital – Madison laboratory services. Any and all resident records, charts or reports produced by client are and remain the property of client. If either party has access to such resident records, it must handle such records in accordance with applicable law and regulations relating to patient confidentiality. The parties agree to execute any documents and take any action required by the Health Insurance Portability and Accountability Act of 1996 with respect to the reports, records and supporting documentation prepared in connection with this Agreement.

SSM Health St. Mary's Hospital – Madison laboratory services is and shall remain at all times in compliance with all applicable laws and regulations in connection with its provisions of laboratory services and billing for services. SSM Health St. Mary's Hospital – Madison laboratory services is and shall remain at all times during the term of this Agreement licensed to provide all types of clinical laboratory testing by the State of Wisconsin, the United States Department of Health and Social Services, Medicare and Wisconsin Medical Assistance. If SSM Health St. Mary's Hospital – Madison laboratory services CLIA certification is suspended or revoked, Client will receive written notification of such and have the option of termination of their agreement immediately.