Clinical Molecular Genetics Diagnostic Laboratory University of Miami, Miller School of Medicine BIO-BANKING COMPENDIUM January 2013 Manual of Service 1501 NW 10th Avenue BRB, Room 445 Miami, Florida 33136
The Dr. John T. Macdonald Foundation Department of Human Genetics Clinical Molecular Genetics Diagnostic Laboratory CMGDL Table of Organization 2013 Massimo Morra, MD, PhD Laboratory Director Revised September 4, 2012 Assistant Director Licensure and Compliance Officer Laboratory Supervisor Interim Chief Financial Officer Mustafa Tekin, MD Lia Breton, MS TBA John Nisbit i
University of Miami, Miller School of Medicine Mission Statement To provide excellence in medical education. To expand medical knowledge through research. To provide high-quality care to those who need it. To be a community partner. ii
General Information Laboratory Director Massimo Morra, MD, PhD 305/ 243-6056 Director, Clinical Molecular Genetics Diagnostic Laboratory MMorra@med.miami.edu Team Members 305/ 243-6671 / 305/ 243-8368 fax Giti Ghaffari, PhD, MB(ASCP), CG(ASCP) GGhaffari@med.miami.edu Mayra Rodriguez, MS, MB (ASCP) MRodrigeuz28@med.miami.edu Lianor Breton, MS, MT (AMT), AHI (AMT), SLS (ASCP), QCYM Regulatory and Compliance Officer LBreton@med.miami.edu Anel Frederick, BS, Systems Analyst AFrederick@med.miami.edu Billing Officer 305/ 243-6583 Deborah Paul Manager, Medical Billing & Collections Geneticsbillingoffice@med.miami.edu iii
Client Support Services Client Support Service is available for all of our clients including: UM physician offices, UM clinics, UM hospitals and all UM campus facilities. The laboratory address is noted below: 1501 NW 10th Avenue BRB, room 445 Miami, FL 33136 (305) 243-6671 The Hours of operation are noted below in Eastern Standard Time: Monday to Friday.9:00 am to 5:00 pm ----------------------------------------------------- Introduction The Clinical Molecular Genetics Diagnostic Laboratory is directed and closely supervised by members of the faculty of the University of Miami, Department of Human Genetics. The laboratory offers Bio-Banking services of the highest quality. This service includes: Blood Sample Storage, DNA Extraction from whole blood specimens and DNA Storage. The lab will also perform Retrieval of Stored Specimens as well as Shipping and Handling of specimens to and from other laboratory sites. In addition to Bio-Banking, the CMGDL performs clinical assays (including genotyping and sequencing). Geneticists are continuously involved in the development of new laboratory test procedures with unique clinical applications. The staff of the Clinical Molecular Genetics Diagnostic Laboratory (CMGDL) is dedicated to the skilled handling and expert processing of laboratory specimens. Specific questions concerning Bio- Banking specimen requirements and special handling procedures should be directed to laboratory personnel at (305) 243-6671. UM Clients may also contact the lab for issues associated with specimen transportation and/or clients may obtain the necessary information by reading this document. Billing Clients must contact the Genetics Billing Office at (305)-243-6583 to establish a Client Account Number prior to forwarding Bio-banking specimens to the laboratory. Communication may also be completed via email Geneticsbillingoffice@med.miami.edu. Please note that specimens will not be processed until billing functions have been approved and cleared. UM Clients should contact the Billing office for invoice inquiries. The CMDGL can only receive payment in US dollars. Clients may provide a draft from a financial institution with a US address. Professional Consultation Both the laboratory director and assistant director are available for consultation on cases. The CMGDL only performs the Bio-banking components that are listed in this document. Specimen Preparation Specimen requirements for Bio-Banking are noted on the laboratory request form. All containers must be properly labeled with the patient s name, DOB, ordering physician name and the date and time of specimen collection. Please close and seal all containers properly to prevent unnecessary exposure to potentially infectious specimens. Specimens must be transported in an appropriate (biohazard) specimen bag. Laboratory request forms must accompany the specimen in an adjacent plastic bag to avoid contamination of request form. In the event a specimen received by CMGDL personnel is unsuitable and/or inappropriate for the requested Bio-banking service, we shall notify the client and or the requesting physician as soon as possible and await instructions OR alternatively return the specimen on the following business day (please see specimens returned). Note** The PRIMARY SPECIMEN container must be labeled with 2 identifiers at the time of collection. (Examples of identifiers include but are not limited to patient name, DOB, hospital number, social security number, unique random number. A hospital room number is not an acceptable identifier). Note ** The Clinical Molecular Genetics Diagnostic Laboratory (CMGDL) does not perform specimen collection. Specimen collection must be performed per client policies and procedures for patient identification, preparation and collection of specimen. iv
Specimen Transportation The courier personnel are specially trained to ensure the proper handling and preservation of all types of specimens. COURIER SERVICES Internal courier transport services are available for clients/physicians located on the UM, Medical Campus. To arrange for specimen pick-up, please call Client Support Services phone number at (305) 243-6671. Specimens emanating from outside of the Dade County area must be transported by the UM courier s from the clinic site to the UM, Miller School Of Medicine, Medical Campus. CMGDL will not be responsible for the specimen until it is received by the laboratory. All laboratory request forms are clocked in documenting the time the specimen is received by the CMGDL personnel. The clocked in time and date is the official time of Bio-banking specimen receipt. Unacceptable Specimens Needles: We will not accept, transport or test any specimen that has or may contain an attached needle. Glass tubes: Glass transfer tubes should be avoided (if possible) due to the increased risk of broken glass and biological contamination. Improperly Labeled Specimens: We will not accept Bio-banking specimens submitted without proper identification; patient name, identification number, age, sex, date of birth, ordering physician, diagnosis and ICD-9 code, physician number, specimen type, date and time of collection, bio-banking request, and a completed Bio-banking laboratory request form which includes a patient consent form. Patient Informed Consent The Patient Informed Consent and Physician /Counselor Statement boxes must be dated and signed on the CMGDL Bio-banking Laboratory Request Form. This is a mandatory requirement. will also accept a written document (email, letter or fax) from the physician stating that bio-banking has been discussed with the patient and/or legal guardian. Specimen Returns Clinical Molecular Genetics Diagnostic Laboratory (CMGDL) will charge the client s account a $15.00 handling fee to cover the cost of returning specimens, if a return is requested by the client. Requests must be made by the submitting laboratory in writing. FedEx account number may be provided in conjunction with request. Allow 2-3 business days for return of specimens. NOTE** The Clinical Molecular Genetics Diagnostic Laboratory (CMGDL) will not be held responsible for returned specimens that may be damaged or lost during return transit. Test Cancellations, Additions, STAT Requests Bio-banking services may be cancelled by UM physicians or client without charge while specimens are in transit to the laboratory. It will be the responsibility of the client to call our lab and send us a written cancellation request via fax (305)-243-8368. Bio-banking cancellations cannot be made after the specimen has been set-up or completed and will therefore be charged the standard published fee. Additional bio-banking services can be arranged if sufficient specimen volume permits. The Clinical Molecular Genetics Diagnostic Laboratory requires that requests for cancellation or addition of bio-banking services be made by the originating / ordering UM physician. Verbal requests are not accepted. A written CMGDL Bio-Banking lab request form must accompany the specimen. Requests for biobanking services must be made in writing by the originating / ordering UM physician. With reference to bio-banking for an affected individual, the signature from the parent of the patient and or legal guardian will be accepted. The CMGDL v
Test Changes The Clinical Molecular Genetics Diagnostic Laboratory continually strides to enhance services and improve the quality of laboratory Bio-Banking Services. In so doing, methodologies and prices are subject to change. In the event of Bio-banking service changes, the UM client will be notified via a comment on the Bio- Banking Quality Report, and the laboratory shall make every effort to contact the ordering UM physician. Notifications shall always be performed per Laboratory Director s (or designee, i.e.: supervisor) instructions. CPT Coding The Clinical Molecular Genetics Diagnostic Laboratory has provided space for CPT Codes in an effort to offer some guidance. The CPT codes listed only reflect our interpretation. It is the client s responsibility to determine the correct CPT to use for billing and verify the accuracy of the codes for the performance of Bio-banking services. The Clinical Molecular Genetics Diagnostic Laboratory assumes no responsibility for billing errors due to the clients reliance on the CPT codes listed in this document. For further reference, please consult the CPT coding manual that is published by The American Medical Association (AMA). If you have any questions regarding the use of a code, please contact your local Medicare carrier. Specimen Requisition Form Please PRINT all information. Complete a separate CMGDL Bio-Banking Laboratory Request Form for each patient. Note: If more than one specimen is being submitted per patient, and specimens need to be stored without processing, it is the responsibility of the UM ordering physician or genetic counselor to provide detailed instructions as to HOW samples are to be processed. A space is provided on the lab request form for this information. It is located directly below the bio-banking order table. Fill in all patient and physician information (patient name, ID number, sex, date of birth, physician name, collection date and time, specimen type, diagnosis, ICD-9 code, physician identifiers, all physician information and forms must contain physician signature). Check the box indicating the appropriate Bio-banking Service requested and submit the original to the laboratory along with the specimen (retain a copy for your records). Laboratory test orders can only be requested by and will only be performed for authorized persons. Additional Bio-banking Lab Request Forms that are specific to your UM practice and contain your Client Account number may be ordered by calling the Client Support Services. Clients may call us at (305)-243-6671. Please have your client account number available for faster service. To establish a new client account number please call the Genetics Billing Office at (305)-243-6583. Communication may also be completed via email Geneticsbillingoffice@med.miami.edu. Please note that specimens will not be processed until billing functions have been approved and cleared. Supplies Clinical Molecular Genetics Diagnostic Laboratory does not provide any specimen collection supplies. Should any question arise regarding acceptable specimen containers, clients may review the Specimen Requirements section of each test page and or refer to the CMDGL Test Tube Diagrams. If additional information or assistance is required please contact the CMGDL laboratory performing the Bio-banking Service at (305)-243-6671. Specimen Shipping Address Clinical Molecular Genetics Diagnostic Laboratory University of Miami, Miller School of Medicine 1501 NW 10 AVE BRB, Room 445 Miami, FL 33136 Letter Mailing Address: University of Miami, Miller School of Medicine HIHG PO Box 019132 (M860) Miami, FL 33101 vi
Out of State Specimens Bio-banking services are provided only for UM clients and UM physicians. The CMGDL will ship previously processed Bio-banking specimens out of state at the request of UM physicians. TEST TUBE DIAGRAM Clients should contact the laboratory prior to shipping any specimen to the lab from outside of the State of Florida. Please contact the CMGDL at (305)-243-6671. Clients are requested to call the Genetics Billing Office at (305)-243-6583. Communication may also be completed via email Geneticsbillingoffice@med.miami.edu. Please note that specimens will not be processed until all billing functions have been approved and cleared. Electronic Compendium An election version of this document is available at: http://medgen.med.miami.edu/cmgdl/search-for-atest. Click on Laboratory Compendium. NOTE**Refer to specific Bio-banking services for detailed information. 01/2013LB vii
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Bio-Banking Services Clinical Molecular Genetics Diagnostic Laboratory University of Miami, Miller School of Medicine BLOOD SAMPLE STORAGE The whole blood specimen is accessioned into the laboratory information system. A unique laboratory identification number is generated and placed into the whole blood specimen. The specimen is then prepared for storage and placed into -20 degrees centigrade temperature freezer. An internal quality report is generated detailing the number of tubes and approximate volume of whole blood that has been stored. Specimen Requirement(s): Collection Tube: Handling: CPT Code(s): Lab Code: 2.0 ml of whole blood (minimum) Lavender Top Tube /w EDTA Room Temp- specimen processed within 24-48 hours Refrigerate (2 to 8 degrees C, stable for 24-72 hours) 81479 9001 Bio-Banking Services DNA EXTRACTION The whole blood specimen is accessioned into the laboratory information system. A unique laboratory identification number is generated and placed into the whole blood specimen. The specimen is then prepared for DNA Extraction. One ml of whole blood is used for one DNA Extraction unit. If 4ml of blood are received and all of the blood is ordered for performance of DNA Extraction, then at the conclusion of the Bio- Banking services, there shall be four DNA Extraction units available. The quality of the extracted DNA is measured via Nanodrop instrument and recorded. An internal quality report is generated detailing the number of DNA Extraction units available and the quality of the extracted DNA. Note ** The DNA Extraction units may be immediately released to the ordering physician or placed into storage in the CMGDL Bio- Banking repository. Specimen Requirement(s): Collection Tube: Handling: CPT Code(s): Lab Code: 2.0 ml of whole blood (minimum) Lavender Top Tube /w EDTA Room Temp- specimen processed within 24-48 hours Refrigerate (2 to 8 degrees C, stable for 24-72 hours) 81479 9002 Bio-Banking Services DNA STORAGE The whole blood specimen is accessioned into the laboratory information system. A unique laboratory identification number is generated and placed into the whole blood specimen. The specimen is then prepared for DNA Extraction. One ml of whole blood is used for one DNA Extraction unit. If 4ml of blood are received and all of the blood is ordered for performance of DNA Extraction, then at the conclusion of the Bio- Banking services, there shall be four DNA Extraction units available. The quality of the extracted DNA is measured via Nanodrop instrument and recorded. The extracted DNA unit is placed into storage at -20 degrees centigrade freezer. An internal quality report is generated detailing the number of DNA Extraction Units that have been placed into DNA Storage and the quality of the extracted DNA. Specimen Requirement(s): Collection Tube: Handling: CPT Code(s): Lab Code: 2.0 ml of whole blood (minimum) Lavender Top Tube /w EDTA Room Temp- specimen processed within 24-48 hours Refrigerate (2 to 8 degrees C, stable for 24-72 hours) 81479 9003 Phone (305)-243-6671 Fax (305)-243-8368 10 Rev. 1/2013 LB
Clinical Molecular Genetics Diagnostic Laboratory University of Miami, Miller School of Medicine Bio-Banking Services Retrieval The Bio-banking specimens (whole blood or Extracted DNA placed into DNA Storage) that have been previously processed and stored are removed from storage. Retrieval may also be performed in the event the ordering physician wants the specimen returned to him/her. Retrieval may also be performed for specimen destruction, which can be completed by the lab. Note** Requests for Retrieval Services must be received on a CMGDL Bio-Banking Lab Request Form that is signed by the ordering physician. All patient information must be provided. If specimen destruction is desired, then the ordering physicians must provide that information in writing under HOW the sample is to be processed. Specimen Requirement(s): Handling: TAT: CPT Code(s): Lab Code: Previously processed specimen Extracted DNA or Whole Blood specimen Frozen -20 degrees C 3 to 5 business days 81479 9004 Bio-Banking Services Shipping & Handling The Bio-banking specimens (whole blood or Extracted DNA placed into DNA Storage) that have been previously processed and stored are removed from storage. The specimens are handled in preparation for Shipping and sent to the location that has been specified by the ordering physician. Note** Requests for Shipping &Handling Services must be received on a CMGDL Bio-Banking Lab Request Form that is signed by the ordering physician. All patient information must be provided. Detailed shipping instructions (name of contact person, shipping address, contact telephone number) must be provided or the Shipping and Handling service will not be completed. Please contact the lab for assistance. Specimen Requirement(s): Handling: TAT: CPT Code(s): Lab Code: Previously processed specimen Extracted DNA or Whole Blood specimen Frozen -20 degrees C Specimens that are refrigerated or at room temp are stable for 24 to 48 hours. 3 to 5 business days 99001 9005 Laboratory Director s Signature of Review: Date: Phone (305)-243-6671 Fax (305)-243-8368 11 Rev. 1/2013 LB