SOP of 2 pages

TECHNICAL PROCEDURE

SOP#

Title:	Keep it short and to the point. Explanations can be entered below
Purpose:	Explain the purpose, intent, to demonstrate the “why” this document is important and necessary
Scope:	This policy applies to XXX workforce and medical staff, unless otherwise specified
Location:	Inpatient Ambulatory Clinics Emergency Services
Population:	All ages Adults Only Pediatrics
Personnel:	All clinically trained staff or MLS RNs / LPNs RTs
Definitions:	Define services, programs, terms, uncommon acronyms or abbreviations

I. Specimen Requirements

A. Patient Preparation

Include instructions for fasting and may reference related document

B. Specimen Collection / Handling / Transport

Include steps for complicated collection procedure as well as special instructions for timing, labeling, transport, storage, preservation, centrifugation, and referral for reflex testing

C. Specimen Acceptability / Rejection Criteria

Include detection of inadequately prepared specimen / slides

II. Equipment and Materials

A. Equipment

Include equipment required to perform the procedures

B. Reagent / Media / Supplies

Include storage criteria and expiration. Include preparation of special stains and reagents used in testing

III. Procedure

A. {Procedure Name]

Step-by-step instructions for equipment use and manual processing steps

B. Calculations

Step-by-step instructions for completing manual calculations. Provide the equation and an example

C. Reporting Results

Step-by-step instructions for entering/accepting results

D. Repeat / Confirmation Criteria

Description of criteria causing a repeat/confirmation and the process to perform

IV. Control Procedures

A. Quality Control

Include frequency (daily, weekly, monthly, lot change processes, etc), storage, and documentation. Include corrective action when tolerance limits are exceeded

B. Calibration

Include frequency (daily, weekly, monthly, lot change processes, etc), storage, and documentation. Include corrective action when tolerance limits are exceeded

C. Linearity

Include frequency (daily, weekly, monthly, lot change processes, etc), storage, and documentation. Include corrective action when tolerance limits are exceeded

V. Maintenance

A. Routine Maintenance

B. Cleaning Instructions

VI. Limitations / Additional Considerations

Include special handling precautions, sources of error, clinical situations that may impact validity of results, and overall limitations of the method

VII. Result Interpretation

A. Reference Intervals

Describe positive and negative results, interpretive data, and expected results

B. Analytical Measurement Range

Describe accuracy of the test (high/low ends) and need for confirmatory testing as applicable

C. Critical Results

D. Troubleshooting

Description of the course of action to take if a test system becomes inoperable

Related Documents:

Appendices: Hyperlinks: You can hyperlink internet websites that are important to the procedure (i.e., CDC webpage). You can also hyperlink to forms, documents, department webpages found on your facilities intranet

Effective Date:

Scope:	Medical Director / Designee	Date
Your hospital	Your Medical director’s signature

Scope:	Patient Care Services	Date
Your hospital	Your signature as lab manager

References

Include citation if procedure demonstrates compliance to legal, regulatory, or other authority (e.g., Federal/State law, CMS, CAP, FDA, TJC

List all references used to determine content, accuracy, and decisions on final content (e.g. package inserts, websites, journals, books, etc.)