Cholestech GDX Guida di riferimento

System

Procedure Manual

TABLE OF CONTENTS >

iTABLE OF CONTENTS
Cholestech GDX System Procedure Manual
Foreword – Procedure Manual Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii
Introduction – Overview of a Quality Assurance Program . . . . . . . . . . . . . . . . . . . .iv
0 Setup and Maintenance
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
2 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
3 Optics Check Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
4 Optics Check Cartridge Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
5 Shelf Life Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
6 Laboratory Temperature Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
7 Instrument History Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
8 Cholestech GDX System Initial Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
9 Maintenance and Cleaning of the Cholestech GDX System . . . . . . . . . . . . . . . . . . .5
10 Course of Action If System Becomes Inoperable . . . . . . . . . . . . . . . . . . . . . . . . . . .5
11 Procedure Sign-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
12 Reference(s) and Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
0 Specimen Collection and Handling
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
2 Fingerstick Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
3 Procedure Sign-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
4 Venipuncture Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
5 Procedure Sign-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
6 Reporting Results Properly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
7 Procedure Sign-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
8 Proper Specimen Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
9 Procedure to Properly Remove a Rubber Stopper from an Evacuated Tube . . . . . .13
10 Reference(s) and Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
0 Quality Control
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
2 Handling Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
3 External Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
4 Control Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
0 A1C Test Procedure
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
2 Medical Importance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
3 Principle of the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
4 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
5 Test Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
6 Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
7 Procedure Sign-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
8 Reference(s) and Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
0 Safety
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
2 Reference(s) and Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Table of Contents
TABLE OF CONTENTS CONTINUE >

ii TABLE OF CONTENTS
Cholestech GDX System Procedure Manual
6.0 Training
6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
6.2 Cholestech GDX Training Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
6.3 Certiﬁcate of Training – Fingerstick Blood Collection . . . . . . . . . . . . . . . . . . . . . . .32
6.4 Online Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
7.0 Material Safety Data Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
8.0 Proﬁciency Testing
8.1 Overview of Proﬁciency Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
8.2 Proﬁciency Testing Agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
8.3 Reference(s) and Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
9.0 Troubleshooting 
9.1 Time/Sequence Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
9.2 Analyzer/Test Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
10.0 Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
10.1 Reference(s) and Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
11.0 Master Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
A1C Result Log
Temperature Chart
Instrument History Record
Information and Service Log
Initial Setup Checklist
Equipment Maintenance/Cleaning Log
Instruments In-Use Record
Patient Result Label Log
Quality Assurance Record
Control Range Calculation Form
Accuracy Study Data
Precision Calculation Form
Training Checklist
Certiﬁcate of Training for Fingerstick Blood Collection
<TABLE OF CONTENTS

iiiFOREWORD

Cholestech GDX System Procedure Manual

Procedure Manual Overview

This Procedure manual has been designed to instruct Cholestech GDX users in how to

comply with good laboratory practices and assist in complying with applicable regulations.

The Cholestech GDX System Procedure Manual covers:

• Setup and Maintenance: Procedure to properly run an optics check and record the

values for the Cholestech GDX System. In addition, the section provides speciﬁc

information about recording laboratory environment conditions.

• Specimen Collection and Handling: General procedures applicable to obtaining a

suitable specimen and running a test on the Cholestech GDX System.

• Quality Control: Discusses laboratory activities designed to ensure that each test system

is working properly and that the test results satisfy quality standards.

• Testing Procedures: A test procedure that covers the Cholestech GDX.

• Safety: Allows you to ﬁle your safety guidelines as recommended by OSHA.

• Training: A checklist as a guideline to train personnel on the Cholestech GDX System.

• Material Safety Data Sheets: A copy of Cholestech Corporation’s MSDS for the

Cholestech GDX test cartridges, controls and Optics Check Cartridge. You can add

MSDSs as required.

• Proﬁciency Testing Guidance: Discusses the importance of proﬁciency testing, how

testing is performed and lists agencies offering proﬁciency testing.

• Master Forms: Master forms are provided for you to copy and use as needed.

An icon (a letter within a shape) will appear at the beginning of each section. These icons

indicate:

Foreword

The information in the following section is “For Information Only.”

The information in the following section is “Recommended” by the manufacturer.

The information in the following section is recommended to comply with OSHA and

CLIA ’88 Moderately Complex Laboratory Regulations, as well as regulations that

apply to users in certain states.

If you need assistance using the manual, please contact Cholestech Technical Service at

800-733-0404.

Please note: The following procedures are outlined as a guide, not a substitute for

complying with state or federal regulations relevant to your site. Cholestech Corporation

does not guarantee that following this guide will result in certiﬁcation or meeting state or

federal regulations. For further information regarding regulations, please refer to your state

or federal agencies.

<TABLE OF CONTENTS

iv INTRODUCTION

Cholestech GDX System Procedure Manual

Introduction

Overview of a Quality Assurance Program

Quality assurance (QA) is a comprehensive set of policies, procedures and practices

necessary to ensure the quality of laboratory tests. Its purpose is to ensure that over the

long term, the laboratory provides reliable data that accurately reﬂect the patient’s status.

Quality assurance in a point-of-care laboratory covers nine basic areas:

1. Policies and standards that govern the laboratory cover elements that affect test quality

before (patient preparation, sample collection, etc.), during and after (data transcription

errors, etc.) the testing process.

2. Training: All personnel conducting tests should be properly trained and their training

documented.

3. Safety policies should be adhered to and a safe working environment provided.

4. Procedure manuals should contain operating protocols that are complete, up to date

and available to laboratory personnel.

5. Record keeping: All aspects of the quality assurance program should be documented in

writing as appropriate.

6. Quality control may include initial veriﬁcation of the test method, routine testing of

quality control materials and a written procedure for responding to “out of control” test

results. All quality control procedures and follow-up actions should be documented.

7. Participation in proﬁciency testing program is optional for CLIA-waived tests. Proﬁciency

testing may be performed and documented when required by local or state regulations.

8. Laboratory inspections may be conducted by the appropriate organization to assess

quality assurance and suggest possible improvements.

A successful QA program assures that:

1. Policies and procedures are established in writing and followed by all personnel

involved in the testing process.

2. The test system performs properly at the time patient results are produced.

3. Written records are available to demonstrate that uniform procedures have been

established and are followed.

The material in this procedure manual can assist in assuring that the quality of test results

in the laboratory or at a testing site are satisfactory over time.

<TABLE OF CONTENTS

1.0 Setup and

Maintenance

<TABLE OF CONTENTS

2SETUP AND MAINTENANCE

Cholestech GDX System Procedure Manual

IRO

For Information Only Recommended Optional Information

1.1 Introduction

This section contains the procedure to properly run an optics check and speciﬁc

information about proper maintenance. A sample copy of each form referred to is included

in the Master Forms section of this manual.

1.2 Environmental Requirements

Use your Cholestech GDX System in a location that has:

• Temperature 63–86ºF (17–30ºC)

• A stable work surface

• No direct heat (oven or room heater)

• No bright light (sunlight or a spotlight)

It is important to prevent dust and dirt from getting into the Analyzer. Keep the Analyzer

covered when not in use.

If the temperature or light requirements are not acceptable, the Analyzer will shut down

until they are met.

1.3 Optics Check Cartridge

The Optics Check Cartridge is reusable. It is designed to check that the Analyzer is working

correctly. The cartridge contains a resin with a dye that acts like your blood sample. The

Analyzer will automatically recognize when an Optics Check Cartridge is being used.

The Optics Check Cartridge should be run every day the Cholestech GDX Analyzer is used.

If you are concerned that your test result is incorrect, also run the quality control material.

1.4 Optics Check Cartridge Test Procedure

Do not use a Cholestech GDX Optics Cartridge that is expired, damaged or altered in any way.

1. Plug in the Analyzer and allow to warm up.

2. Place the cartridge in the Analyzer when the Insert Cartridge icon ﬂashes.

• “ ” appears on the display and the Hourglass icon is displayed.

• The Rotate Cartridge icon is displayed. The Analyzer will beep and the light at

Position 1 will ﬂash.

3. Turn the cartridge to Position 1.

• “ ” and the Hourglass icon will show on the display.

• The Rotate Cartridge icon will be displayed. The Analyzer will beep and the light at

Position 2 will ﬂash.

4. Turn the cartridge to Position 2.

• “ ” and the Hourglass icon will show on the display.

• The Rotate Cartridge icon will be displayed. The Analyzer will beep and the light at

Position 3 will ﬂash.

Setup and Maintenance

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3SETUP AND MAINTENANCE

Cholestech GDX System Procedure Manual

IRO

For Information Only Recommended Optional Information

5. Turn the cartridge to Position 3.

• “ ” and the Hourglass icon will show on the display.

• The Rotate Cartridge icon will be displayed.

6. Turn the cartridge to Position 0.

• The Remove and Cartridge icons will be displayed.

7. Remove the cartridge.

• The Analyzer will display the result: e.g., C 10.7%

8. Record the results in the Cholestech GDX A1C Result Log each day.

Note: “ ” stands for Optics Check Cartridge.

9. Press the “enter” button to clear the Optics Check Cartridge result.

Storage

Always store the Optics Check Cartridge at room temperature in its box. This will help to

protect it from damage such as scratches, which may affect the result.

The cartridge must not be left in direct sunlight for long periods while not in use.

The Optics Check Cartridge must be stored at relative humidity of less than 60%.

Results

The results displayed on the Analyzer at the end of Optics Check Cartridge test must be in

the range on the cartridge label.

If the result does not fall within the range displayed, do the following:

• Clean the clear plastic surface of the cartridge with a soft, lint-free cloth. Do this

on the inside and outside of the cartridge. Follow the test from point 2.

• If the result is still not in the correct range, restart the Analyzer by unplugging

and replugging it and run the Optics Check Cartridge.

• If the result is still not in range, contact Cholestech Technical Service.

• If the cartridge is physically scratched, dirty or damaged, replace the cartridge

with a new Optics Check Cartridge.

Warning: For In Vitro Diagnostic Use

When the test is ﬁnished, the Optics Check Cartridge should be returned to its protective

packaging for storage. Do not use the Optics Check Cartridge if it has been stored

incorrectly and is scratched or damaged in any way.

For technical help and troubleshooting, please refer to the Cholestech GDX A1C Test

Cartridge package insert and the User Manual. If technical help is required, please contact

Cholestech Technical Service at 800-733-0404.

1.5 Shelf Life Stability

Optics Check Cartridges have a shelf life date. The expiration date is printed on the top of

the Optics Check Cartridge. Do not use the Optics Check Cartridge after the end of the shelf

life date.

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4SETUP AND MAINTENANCE

Cholestech GDX System Procedure Manual

IRO

For Information Only Recommended Optional Information

1.6 Laboratory Temperature Records

Forms are included in this manual (see Master Forms section) to record the temperature of

the laboratory room and refrigerator. Each form is designed for a daily record to be

recorded. There is space for the site identiﬁcation, the acceptable temperature range and

daily temperature records. Record the temperature and your initials in the allocated spaces.

1.7 Instrument History Record

Proper, continuing care for a laboratory instrument has primary importance, as it minimizes

breakdowns and ensures proper results.

The Instrument History Record allows lab personnel to communicate effectively with

Cholestech Technical Service. You should have a record for your Cholestech GDX System

as well as records for any other instruments in the lab (refer to the Master Forms section of

this manual).

Several general guidelines are helpful in ensuring satisfactory preventive maintenance:

• Select one person to have principal responsibility for a given instrument.

• Make sure that this person is familiar with the user manual, the procedure

manual and the package insert for each test system.

• Perform all required preventive maintenance called for in the Cholestech GDX

Analyzer User Manual.

• Keep all spare parts recommended by the manufacturer on hand.

1.8 Cholestech GDX System Initial Setup

The Initial Setup Checklist is provided to assure that all of the environmental conditions

are met and that the Cholestech GDX System runs properly during the initial setup in

the laboratory. Refer to the Master Forms section of this manual.

The Instrument History Record can be used to record any service performed on the

Cholestech GDX System or other instruments in your laboratory. Both forms can be found

in the Master Forms section of this manual.

Cholestech Corporation will provide technical support to each Cholestech GDX System user.

Any questions regarding the operation of the Cholestech GDX System may be directed to:

Cholestech Corporation

Technical Service Department

3347 Investment Blvd.

Hayward, CA 94545 U.S.A.

Tel 800 733.0404

Fax 510 732.7227

www.cholestech.com

[email protected]

<TABLE OF CONTENTS

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