New Articles:

• April 2009 Changes:
  • Now Accepting United Health Care Insurance
  • New Hours at Patient Service Centers
• Labeling for Confidential Testing
• Now Offering Bacterial Vaginosis Testing by PCR
• Why Didn't We Get Sensitivities on our Patient's Culture?
• HPV Testing Changes
• Partial Hysterectomy Patients and Pap Testing
• On-Line Computer Access a Success
• Laboratory Testing on Minor Children

Technical Updates (Adobe Acrobat Documents):

There are no new updates available for our Reference Manual (dated January 2007). You can print the entire manual off of our website, by clicking the link above.

Please ensure you are making updates to our most recent edition of our Reference Manual, dated January 2007.

Archived Articles:

• Significant Reference Range Change: CK-MB & Troponin
• BDProbeTec - Increased Sensitivity for the Detection of Chlamydia and Gonorrhea
• TRICARE Patients: See our ad under "Laboratory Services" in the 2004 Naval Hospital Jacksonville Patient Guide (page 72) and Mayport Patient Guide (page 36). Phone numbers and maps to all Patient Service Center locations provided. Please note, in the online versions, only the Mayport Patient Guide includes the CLS advertisement.
• Medicare denies General Health Panel ***
• CLS Client HIPAA BUSINESS ASSOCIATE AGREEMENT ***
• ThinPrep® is an accepted method of testing for CLS beginning April 1, 2003. ***
  
• View our pathology brochures.
  
• The Use of Client-Designed Test Requisitions
  
• Q.I. Corner
  
• Commonly Asked ABN Questions
  
• Medicare Compliance
  
• Medical Technologists & SVMC Internship Program

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April 2009 Changes

Effective April 12, 2009:

Consolidated Laboratory Services is now a provider for United Health Care Insurance.
Click here for the list of United Health Care plans accepted. ***

New Hours at Patient Service Center locations. ***

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Labeling for Confidential Testing

From time to time, offices may wish to submit a laboratory sample for testing, and maintain a higher degree of confidentiality. A confidential sample may be submitted by using an alphanumeric identifier in place of the patient's first and last name. A social security number, chart number, randomly generated identifier, or a number from a sequential series of numbers may be used for such an identifier.  Unique identifiers should be between four (4) and ten (10) characters in length.

Offices have found greater success using a consistent approach to labeling these types of specimens. You may elect to use a simple identifier such as practice last name as a consistent LAST NAME, then assign the patient's social security number or chart number as the patient's FIRST NAME.  As an example, patient "123456789" obtains a sample. The specimen would be labeled as "RPS, 123456789", and the test request form would show "RPS" as the last name and "123456789" as the first name.

Whatever system your office elects to use, the same identifier must appear in place of the patient name on both the specimen and the test request form. When using a unique identifier, your office must maintain the paperwork that allows you to match the unique specimen identifier with your patient.

If you need additional clarification or assistance regarding these labeling requirements, please contact your Sales / Service Representative.

Now Offering Bacterial Vaginosis Testing by PCR

This document is viewable with Adobe Reader. Click here to download the free Adobe Reader, if you don't already have it installed.

It is paired with the "Why Didn't We Get Sensitivities on our Patient's Cultre?" document.

Click here to view the document.

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Why Didn't We Get Sensitivities on our Patient's Culture?

This document is viewable with Adobe Reader. Click here to download the free Adobe Reader, if you don't already have it installed.

It is paired with the "Now Offering Bacterial Vaginosis Testing by PCR" document.

Click here to view the document.

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HPV Testing Changes

Consolidated Laboratory Services is pleased to announce that, effective April 10, 2006, we will begin offering high-risk (only) HPV testing.  While testing for both low-risk and high-risk has been our standard for some time, both consensus and community standards are that only high-risk HPV testing is necessary or indeed appropriate for ancillary screening or follow-up testing of abnormal “ASCUS” results. With that in mind, only high-risk HPV testing will be performed any time our test requisition is marked for either “Reflex HPV testing”, or “HPV testing regardless of result” when ordered in conjunction with a Thin Prep Pap.

Low-risk HPV testing may be desirable in select instances, for example as a surrogate test for sexual activity, etc. Clinicians who wish to test patients for both low and high-risk HPV strains should indicate this by writing “Low and High Risk HPV” in the comments section of the Consolidated Laboratory Services Test Request form.

If you have any questions regarding this change, please contact our Customer Call Center at 904-308-5600.

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Partial Hysterectomy Patients and Pap Testing

With the advent of assorted new methodologies for surgical excision of benign uteri, supracervical hysterectomies are becoming increasingly common. It is extremely important that our Cytotechnologists and Cytopathologists are aware of the presence of a residual cervix when submitting a Pap Smear or Thin Prep of a patient whose clinical information indicates hysterectomy.  The presence of endocervical cells in such a patient will automatically trigger concerns regarding vaginal adenosis or more serious lesions. 

Please write “partial hysterectomy” or “supracervical hysterectomy” in the Significant Clinical History section of the test requisition when submitting a Pap Smear/Thin Prep on these patients to prevent unnecessary telephone calls or unnecessarily alarming reports.

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On-Line Computer Access a Success

Our internet-based laboratory system, 4Medica, has been a huge success.  More than 350 physician offices currently enjoy the convenience of real-time result availability, customized print times, and same-day results in many cases. These same office have the ability to order their lab tests online and have a requisition print for the appropriate laboratory based on the patient's insurance.

If you have a Windows based PC running Windows XP or Vista and would like to see a demo of this system in your office, please contact your Sales/Service Representative. If you don't have a Representative, contact us here and we'll have one contact you.

4Medica Guides

• User's Guide
• Required IE Settings for 4Medica

These documents are viewable with Adobe Reader. Click here to download the free Adobe Reader, if you don't already have it installed.

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Laboratory Testing on Minor Children

Offices are reminded to provide a valid guarantor name when submitting laboratory specimens on minor children. Please be certain to write the full name and address of the guarantor in the box entitled “Responsible Party Name and Street Address” located on the CLS test requisition. Missing guarantor name and/or address will result in phone calls to your office to obtain this necessary billing information.

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Significant Reference Range Change: CK-MB & Troponin

On February 7, 2006 the St. Vincent’s Medical Center Laboratory will begin conversion to a new highly automated and sophisticated chemistry analysis system.  The new system will result in increased specificity and sensitivity and decreased turnaround times in many of the assays. 

THIS CONVERSION WILL RESULT IN SIGNIFICANT REFERENCE RANGE CHANGES FOR CK-MB AND TROPONIN (see table below).

While these new ranges will be flagged and printed on the report with the patient’s result, we feel it is of particular importance that you are aware of the significant CK-MB and the Troponin changes prior to the conversion.

Although the conversion will begin on February 7, not all of the affected assays will move to the new system immediately. As assays are moved, test results will be flagged and the new reference ranges displayed. Please see the back of this page of a list of all affected assays, along with the new reference ranges.

Any questions may be addressed to Ricardo Ramos, MD or Brian Vitsky, MD by calling our Call Center at 308-5639.

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BDProbeTec - Increased Sensitivity for the Detection of Chlamydia and Gonorrhea

August 2004

Consolidated Laboratory Services is pleased to announce a change in methodology for Chlamydia trachomatis and Neisseria gonorrhoeae testing. We are changing from a direct probe method (GenProbe®) to a more sensitive amplified detection method. Amplified technology, with its increased sensitivity, enables earlier detection for improved patient outcomes. Increased sensitivity can produce positive results, even though the patient may be asymptomatic.

The BDProbeTec Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays are based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescent labeled detector probe. The testing procedure uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males.

SAMPLE COLLECTION AND TRANSPORT
The BDProbeTec ET System is designed to detect the presence of C. trachomatis and N. gonorrhoeae in endocervical swabs, male urethral swabs and male and female urine specimens using the appropriate collection method. Only BDProbeTec C. trachomatis /N. gonorrhoeae (CT/GC) Amplified DNA Assay Collection devices can be used to collect swab specimens for testing on the BDProbeTec ET Instrument. GenProbe® swabs are no longer acceptable.

Swab Specimen Collection
Endocervical Swab Specimen Collection using BDProbeTec ET CT/GC Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit:

1. Remove excess mucus from the cervical os with the large-tipped cleaning swab provided in the BDProbeTec ET CT/GC Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit and discard.
2. Insert the Endocervical Specimen Collection and DRY TRANSPORT swab into the cervical canal and rotate for 15-30 sec.
3. Withdraw the swab carefully. Avoid contact with the vaginal mucosa.
4. Immediately place the cap/swab into the transport tube. Make sure the cap is tightly secured to the tube.
5. Label the tube with patient information and date/time collected.

Male Urethral Swab Specimen Collection using BDProbeTec ET CT/GC Amplified DNA Assay Male Urethral Collection and DRY TRANSPORT Kit:

1. Insert the Male Urethral Collection and DRY TRANSPORT swab 2-4 cm into the urethra and rotate for 3-5 sec.
2. Withdraw the swab and place the cap/swab into the transport tube. Make sure the cap is tightly secured to the tube.
3. Label the tube with patient information and date/time collected.

Swab Storage and Transport
Time and temperature conditions for storage must be maintained during transport.

After collection, the endocervical swabs and the male urethral swabs must be stored and transported to the laboratory and/or test site at 2-270°C within 4-6 days.

Urine Specimen Collection

1. Urine specimens must be collected in a sterile, plastic, preservative-free, specimen collection cup.
2. The patient should not have urinated for at least 1 hr. prior to specimen collection.
3. The patient should collect the first 15-20 mL of voided urine (the first part of the stream, NOT midstream).
4. 4. Label with patient identification and date/time collected.

Urine Storage and Transport:

1. Store and transport urine specimens to the test site at 2-8?C within 4-6 days of collection.

Additional questions regarding this change should be directed to your Consolidated Laboratory Services Sales/Service Representative or our Customer Call Center at 308-5600 prompt #2.

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View our pathology brochures.

• Cytology ***
• Dermatopathology ***
• Surgical Pathology ***
• Women's Services ***
• CLS Overview ***
• Plastic Surgery ***
• Research Studies ***
  
• View Dr. Bernstein's announcement ***
  
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The Use of Client-Designed Test Requisitions

More and more physician offices are using computer software programs designed to print a generic laboratory order form that can be used for any reference laboratory. While CLS provides each client with their own requisition, we recognize that a generic form may offer some benefits. If your office uses a generic computer-generated laboratory order form, please be certain your version includes the following:

• Your CLS client account number in a clearly recognizable manner.
• Your client account number can be found in the lower right-hand corner of the "Referring Physician, Client" information box on your current CLS test requisition. Lack of a CLS account number, or listing the number in an unclear manner, may delay or misdirect delivery of patient test results.

Only Medicare-approved panels. If your order form includes a panel or profile that is not recognized by a single CPT code, i.e., "Coagulation Panel", "Anemia Profile", etc., you must also list the individual components so that the proper tests can be ordered and performed. If in doubt, please consult the CLS Reference Manual for recognized panels and profiles. Unclear orders may delay testing until clarification can be obtained.

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Q.I. Corner

If you collect specimens at your office for testing at CLS and complete a CLS Test Requisition (TR), please note the following:

Each completed TR provides four copies of the patient's test order. The routing of each page is printed at the bottom, i.e., the first two should be forwarded with the specimen to the lab, the third ply can be offered to the patient, and the client copy should be retained at your office for specimen tracking, We ask your assistance in providing the original top two copies to the lab for accurate processing. Please do not send copies of the TR with the specimen.

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Commonly Asked Questions Regarding Advanced Beneficiary Notice of Non Coverage

Most physician offices are routinely using an ABN to obtain payment for a variety of limited-coverage Medicare services. As an added feature to our Test Request form, we have identified the most common limited-coverage laboratory tests and provided an ABN to give to your patient. Please review these questions to be certain you are complying with Medicare regulations.

1. What is an ABN?
   An ABN is a written document used to notify a Medicare patient that Medicare will deny payment for the ordered test(s) and to indicate the patient's agreement to accept responsibility for payment.
2. Should I complete an ABN on all Medicare Patients?
   NO! Do not have all Medicare patients complete ABN's. Complete an ABN only if you believe Medicare will deny payment for indicated test(s) which have been ordered.
3. How will I know that Medicare will deny payment?
   Medicare publishes a list of limited coverage tests. Contact us if you need a current listing. This listing provided to you by Consolidated Laboratory Services is not meant to suggest or in any way influence the selection of an ICD-9 code, nor is it the intention of Consolidated Laboratory to suggest or imply that physicians or their representatives should select only the ICD-9 codes that are listed in this manual. The ICD-9 code should accurately reflect the patient's medical condition.
4. What information should be provided on the ABN before collecting the specimen?
   Complete the test request form as usual noting the patient's name exactly as it appears on their Medicare card, date of birth, Medicare number, and the physician's name. Then open the test request form to the patient copy (3rd ply) and check the indicated non-covered test(s) listed on the back under the appropriate reason why Medicare will deny payment.
5. When should I have the patient sign the ABN?
   You must have the ABN completed and signed before any non-covered specimen is collected. Review the information with your patient and have them (or guardian) sign in both signature lines on the front of the test request form. Remove the patient copy (3rd ply) and give to the patient. ABN's are invalid if completed after the specimen has been collected.
6. Do I need to complete an ABN if I am sending our patient to a Service Center?
   YES!!!! Your patient may have questions as to why the test was ordered. The only person who can answer these questions will be their physician. Once the patient arrives at our service center, the only information our staff can give is that your patient will be billed if the test is done.
7. What is the cost for the non-covered laboratory test(s)?
   Patients will be billed according to the Medicare Fee Schedule, a commercially available document published by the government. The patient will not have to pay at the time of service. They will receive an itemized statement from our Billing Department that can be reviewed before sending in a payment. If patients have any questions, they can contact our Billing Department Customer Service number at 308-5657.

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Medicare Compliance

Medicare has implemented more changes in order to reduce fraud. In order to comply, we need your assistance. When completing a test request form for any Medicare patient, please write the patient's name "EXACTLY" how it is printed on their Medicare card. No "Nick Names" please. For example, if your patient prefers the name Bob, but this name on his Medicare card is Robert, please write Robert. If your patient is a Sr or Jr, this information must also be provided. The following is an example of the proper usage for the full name: Robert G. Carter, Jr. Thank your for helping us serve your patients.

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Medical Technologists & SVMC Internship Program

Have you ever wondered who's running the laboratory tests that leave your office each day? Is the testing done solely by robotics and hi-tech, computerized instruments or are there real people serving you in the lab?

It may surprise you to find that there is a whole team of laboratory professionals at work around the clock performing and analyzing the many different diagnostic tests ordered each day. The staff of Consolidated Laboratory Services includes over 150 licensed laboratory professionals working in seven different scientific specialties: Hematology, Chemistry, Microbiology, Immunology, Immunohematology, Cytology, and Histology. Most of these clinical laboratory scientists are called Medical Technologists.

A career as a Medical Technologist begins with a Bachelors degree in Medical Technology, Biology, Chemistry, Microbiology or other related science fields. After college, students spend one year in a Medical Technology Internship Program where they continue their education and get hands on training and experience in all areas of clinical laboratory science. Graduates are qualified for certification as Medical Technologists by the American Society of Clinical Pathologists (ASCP) and for state licensure by the Florida Department of Health, Board of Clinical Laboratory Personnel.

St. Vincent's Medical Center began a Medical Technology Internship Program over 40 years ago. Today, the SVMC School of Medical Technology is one of only five hospital-based internship programs in the state of Florida. Eight to ten student interns are accepted each year with applicants coming from all over the United States. This educational program is funded by St. Vincent's Medical Center and students pay no tuition. Many members of the SVMC medical technology staff are graduates of the program.

Other professionals within the laboratory include Cytotechnologists, who screen cells under the microscope for signs of cancer and other diseases, Histologic Technicians, who prepare and stain sections of body tissue for analysis, and Medical Laboratory Technicians, who have completed an Associates degree in clinical laboratory science.

We invite you to tour the laboratory and see the work that is being done by Medical Technologists and other laboratory professionals. For more information, call Lynnette Chakkapak at 308-3817.

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