Admin Guidelines 1
An active cellular immunotherapy product manufactured by Dendreon Corrporation. MNC0002.
What is Provenge?
MNC Center Medial Director Responsibilities. MNC0005.
What are providing input on policy and procedures, final approval of patient for collection, ensure compliance with safety standards, adverse event care, be available for consult during procedures, ensured adequate training, respond to patient questions related to MNC informed consent?
Obtains MNC Informed Consent for the apheresis procedure. MNC0011.
Who is the tech performing the collection?
The number of gel packs required per Dendreon shipment and their respective temperatures. MNC0012
What is one (room temp gel pack) and two (gel packs that have been refrigerated for at least 8 hours prior to collection)?
This person can give a patient oral calcium?
Who are the tech/phlebotomist, RN or MD?
AABB & FDA. MNC0002.
What is the American Association of Blood Banks and the Federal Drug Administration?
Physician Designee when Dr. Mack is unavailable. MNC0005.
Who must have the same training as the Center Medical Director? (Dr. Chaffin, Dr. Hopkins, etc.)
Informed Consent for the MNC collection is obtained ___ times.
What is once for all three procedures?
Files are forwarded to this person after the collection and documentation are complete. MNC0502
Who is the AC? Using the AC mailbox in SD or taking the file to the AC's office.
This is the only person who can approve administration of intravenous (IV) calcium gluconate.
Who is the FMD, Dr. Mack or designee?
Functions of the AWP. MNC0009.
What include communication, patient scheduling, printing documents, collection data entry and ordering supplies?
MNC Staff Qualifications. MNC0006.
What are CPR certification, MNC task training, staff with min of 6 months experience in apheresis or therapeutic services, LVN/LPN, MT, RN licenses?
1st and 2nd Steps of Site Setup (Opening Procedure). MNC0012
Which includes 1 (turning on pcs and printers) and 2 (record site evaluation and QC)?
This person holds the thermometer probe while taking oral temperature. MNC0036
Who is the tech/phlebotomist?
The form number and location for a intravenous (IV) calcium gluconate order.
What is BS 874? Where is EDMS?
This Vitalant department Standardizes technical policies and stand operating procedures in the MNC Procedure Manual. MNC0004
What is Central Office?
Minimum Lab and vital sign values for MNC Collection. Including Hct., Hgb., WBC, Plt.) MNC0007. MNC0036.
What are Hct >= 27, Hgb >= 9.0, WBC between 1.5 and 60 uL, Plt >= 50,000 and temp <99.6F?
These documents are faxed to the provider immediately after a Dendreon Research Collection. MNC0012
What are the Procedure Record, Apheresis Progress Notes and the Research Adverse Events form?
After collecting a blood sample the tubes are inverted ____ times. MNC0038
What is 5 times for red top and 8-10 times for other tubes.
The process for correcting information on a record or form. MNC0501.
Which includes do not obliterate or obscure any entry, make corrections by striking a single line through the incorrect entry, record the correction nearby, record EC and date?
Enter a dash or NA in fields that do not require data. Enter one diagonal line across blank cells in a table.
The four main qualifications required to act as program director of MNC collection service. MNC0005.
What are regulatory requirements (set by CFR, AABB, etc.), jurisdiction licensure, at least one year experience in Apheresis collection, CEs?
Primary communication tool between Vitalant and Dendreon Corporation. MNC0009.
What is Intellivenge Apheresis Web Portal?
Patient identification must contain... MNC0031
What is their picture, name, date of birth and ID expiration date?
This is the first step of the Phlebotomy Procedure. MNC0505
What is hand washing and donning gloves?
Daily Double:
This arm is started first?
This person is responsible for accessing a Cenral Venous Catheter (CVC). MNC0506, MNC0507.
Who is an LPN, RN or physician?
Bonus: Who can perform the procedure once the CVC has been accessed by the RN and attached to the kit?