COLA Primer 1 - The Procedure Manual - Required Elements of a Laboratory Procedure

Oct 22, 2026

COLA Primer 1: The Procedure Manual provides a structured guide for laboratory procedure manuals, outlining how procedures should be organized to support consistent, standardized testing across pre-analytic, analytic, and post-analytic phases. It specifies responsibilities for review and approval under CLIA, including required signatures, delegated biennial review conditions, and electronic documentation requirements. The primer details required procedure elements such as patient preparation, specimen handling, acceptability criteria, notifications for unacceptable specimens, reagent and control handling, calibration and verification steps, corrective actions, testing instructions, microscopy standards, calculations, derivation methods, and reporting ranges with critical value notification.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages5

Reading Time13 min

AccessFree to download

Introduction

Responsibility

Creating a Procedure Manual

Required Elements of a Laboratory Procedure

Test name and patient/specimen requirements

Specimen acceptability and rejection criteria

Patient and physician notification for unacceptable specimens

Reagents, calibration, controls, and corrective actions

Step-by-step testing, microscopy, calculations, and result derivation

Reference ranges, reportable ranges, critical values

COLA PRIMER 1 The Procedure Manual •Introduction • Procedure manuals are the road map to a high quality laboratory. They provide direction for all phases of testing, from the pre-analytic phase through the analytical and post-analytical phases. A good manual can also be an excellent resource for training of employees, ensuring that each testis performed in the same way, which ensures standardization. • Responsibility • One of the laboratory director’s responsibilities defined by CLIA is to have an up-to-date manual that has been reviewed and approved by the laboratory director. The importance of approval is to ensure the test selected has the capability to provide quality results that meets the laboratory needs. Each new procedure needs to be approved, signed and dated by the current laboratory director. This approval needs to take place before the procedure is implemented. Also any changes to procedures must be approved and dated before the change is implemented. These responsibilities cannot be delegated. If the laboratory has a new director, it is required that they review and approve all procedures as soon as they take responsibility for the position. Signatures can be electronic as long as they are password protected. A biennial review of the procedure manual is required by COLA. This review can be delegated, such as to a technical consultant, as long as there have been no changes or new procedures. • Creating a Procedure Manual • A procedure manual can be created by organizing printed procedures into a binder. Operator manuals and product inserts are a valuable reference and can be used as a basis for a procedure. If they are used as your procedure or part of your procedure, make sure the laboratory director has reviewed and signed the manual or insert. If you are writing your own procedures, follow the four “C’s”: A good procedure will be: 1. Clear-use terminology that staff can understand 2. Concise-stick to the basics, don’t get too wordy 3. Consistent-use a similar format 4. Complete-include pre analytic, analytic and post analytic phases Electronic procedures are also acceptable as long as the laboratory director is able to produce documentation of dated approval for each procedure. Electronic procedures also have to be readily available to staff and be available in some form if the computer system goes down. • Required Elements of a Laboratory Procedure • • The test name • Directions for patient preparation , specimen collection preservation, storage and handling 1. Any special preparation such as fasting 2. Type and amount of specimen required 3. Collection container required 4. How specimen is handled and stored-room temperature, refrigerated, frozen • Written instructions for the collection and storage of specimens that patients would collect themselves Have written instructions that patient can take home with them. Include a contact if they have questions. • Criteria for specimen acceptability and rejection of unacceptable specimen This can include such things as patient not fasting, hemolyzed, lipemic, etc. Refer to product insert to see acceptable specimen criteria. • Instructions for patient and physician notification if a specimen is unacceptable The reason for unacceptability should be documented, whether testing can still be performed but results might be compromised or testing cannot be performed. Document who was notified of the problem. • Directions for preparing and storing reagents, stains, standards and controls All materials should be labeled as to content, date of preparation and expiration. See product inserts for expiration criteria. Some reagents or control materials may have anew expiration date upon opening. • Directions for calibration, calibration verification and corrective action failures Need to include the following: ▪ Type and concentration of materials to be used ▪ Number of calibrators required ▪ Step by step instructi

FAQs

Who must review and approve the laboratory procedure manual, and what does approval cover?

The laboratory director is responsible for having an up-to-date manual reviewed and approved. Each new procedure and any changes must be approved, signed, and dated before implementation, with approval responsibilities not delegable.

What makes a specimen acceptable or unacceptable, and how is this documented?

The procedure must define criteria for acceptability and rejection, including examples such as not fasting or hemolyzed/lipemic specimens. The reason for unacceptability should be documented, including whether testing can still occur with compromised results and who was notified.

What key elements must be included in a required laboratory procedure?

Required elements include the test name, patient preparation and specimen collection/storage instructions, written patient instructions, specimen acceptability criteria, notification steps for unacceptable specimens, reagent and labeling guidance, calibration and corrective actions for failures, quality control procedures and criteria, step-by-step test performance, microscopy and reporting criteria, calculations/interpretations, result derivation method, and reference/reportable/critical value notification rules.

Oct 22, 2026

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