STANDARD OPERATING PROCEDURES (SOPs) F Frias What is SOP?

This is a detailed plan on the procedures to be taken from the time a sample reaches the laboratory to the issuing of the results. Detailed written instructions to achieve uniformity of the performance of a specific function Used for internal training Documents standardized performance to external reviewers Method to harmonize sites What is in the SOP?

Name of test Test procedure Further tests based on first result

Type of sample Interpretation of result Issuing of results

Components of an SOP Title Procedure References Approval/signature SOP number Rationale Initiation date Purpose Supplies Review date

Title and Number

Title Make it descriptive but short Obtaining Informed Consent Number Catalog and number each SOP Sequential Update number (i.e. SOP 16; SOP 16.1) Statement

To describe the procedure for Why are you doing this procedure? Statement may also include: This procedure involves Alternate or other related procedures Procedure

Describe each step in the procedure (e.g. Phlebotomy SOP) Identify volunteer by name and ID Apply gloves Apply tourniquet Cleanse skin with antiseptic Hold skin taut over vein Insert Vacutainer needle Fill required tubes Remove needle, apply pressure, and bandage

Rationale Why are you doing this procedure this way? For example: Phlebotomy SOP

Procedure Rationale
Apply Gloves Hold skin taut over vein Comply with Universal Precautions To anchor the vein for blood draw Cleanse skin with AntisepticTo prevent infection from skin surface

Supplies

List all supplies needed Gloves Alcohol wipes Vacutainer blood draw needles and barrel Tourniquet Vacutainer tubes Bandage strip

If specific or unusual supply need List brands and order information References

Regulations/guidelines Code of Federal Regulation number ICH guideline number Other organizations Red Cross, CDC, State of Maryland, UN

Supporting references Journal articles Chapters 10 Dates and Approvals

Initiation date: When was this first written and adopted? Review date When was it last reviewed? Approval IndividualPI, Coordinator Review committee/team Advantages of SOP

Clearly defined guidelines to be followed No ambiguity - everyone follows the same guidelines Standard way of reporting