Winchester Hospital of the Valley Health System has summarized the IQCP information from multiple resources and distilled it down to a short primer. Perhaps these are the plans you're looking for.

An IQCP Primer: Instructions for Developing an IQCP

Joseph Litten, PhD
Winchester Hospital
Valley Health System
January 2016

[Editor's note: this is an example of an IQCP guide developed for internal use by a US laboratory. While we at Westgard QC might disagree in principle with some of the of risk assessment advice in this document, this is nevertheless a real-world implementation of IQCP.]

1. Getting Started: Does the test qualify for IQCP

a. Are at least two external controls run each day of patient testing?

b. Is the method a waived test?

c. CAP requires the method have an internal control system for a test to qualify for IQCP. If the method does not have an internal control system, the test does not qualify for IQCP.

NOTE: Laboratory Director must delegate in writing to qualified personnel the development and implementation of the QCP’s.

2. Gather and Review Information

a. Resources for Review

i. Laboratory procedures/SOPs

ii. Manufacturer’s instructions/package insert

iii. Manufacturer’s alerts and technical bulletins

iv. FDA alerts

v. Validation Studies

vi. Calibration data

vii. Historical QC data, including data from a previously conducted equivalent quality control study

viii. Instrument correlation data

ix. Proficiency results and data

x. Records of complaints and corrected reports

xi. Regulatory and accreditation requirements

xii. Scientific publications

xiii. Test process flow charts or maps

xiv. Testing personnel training and competency records

b. Key sections of Package Inserts to Review

i. Intended use

ii. Patient preparation

iii. Limitations

iv. Environmental requirements

v. QC frequency

vi. Specimen Requirements

vii. Reagent storage

viii. Maintenance

ix. Calibration

x. Interfering substances

c. A single risk assessment may be performed with a method that is used in multiple settings

i. However, differences in testing personnel and environments where the test systems are used must be taken into consideration. In these cases, a risk assessment for each individual location and/or device must be performed.

ii. Validation documentation must be available for each test system

3. Risk Assessment

a. Assessing SPECIMEN Risks

i. Things to consider

1. Patient Identification

2. Patient Preparation

3. Specimen Collection

3a. Tube type, etc

3b. Site Preparation

3c. Specimen contamination

3c.i. Presence of IV’s

3c.ii. Alcohol or other cleansing agents

3c.iii. Anticoagulants in line

3d. Poor circulation at sample site

3e. Poor technique

3f. Inadequate sample volume - partial draw tube

4. Specimen Identification

5. Specimen Stability (Storage)

6. Specimen Integrity

6a. Lipemia, hemolysis

6b. Interfering Substances

6c. Clotting of Specimen

6d. Air in syringe

6e. Sample exposed to air

6f. Improper sample handling

ii. Example - see Appendices A and B

b. Assessing TEST SYSTEM (Device) Risks

i. Things to consider

1. QC Results

1a. Does the system prevent patient results from being reported when QC is unacceptable?

1b. Documenting QC results

2. Specimen Volume

2a. Application – over filling, under filling detection

2b. Built in monitors?

3. Clot detection capability

4. Time limit to read device

5. Maintenance

6. Is the test performed outside its intended use per manufacturer’s instructions?

7. Limitations of the test system

8. Transmission of results

9. Positive specimen Identification

10. Operator lockout

11. Mixing of specimen

12. Dirty optics, scratches, contamination

13. Optics drift

14. Electronic instability

 

c. Assessing REAGENT Risks

i. Things to consider

1. Storage Requirements

2. Monitoring of Storage Temperature

3. Humidity Requirements

4. Monitoring Room Temperature Storage

5. Ability to Used Expired Reagent

6. Reagent Preparation

7. Integrity of Shipped Reagents

8. Reagent with different lot numbers

9. Specified type of water required

10. Quality control material and calibrator degradation

 

d. Assessing ENVIRONMENT Risks

i. Things to consider

1. Room Temperature Range

2. Proper Ventilation of Instrument or Device

3. Space Requirement

4. Lighting

5. Humidity

6. Workspace – free of clutter, dust or debris

 

e. Assessing PERSONNEL Risks

i. Things to consider

1. Training

2. Competency

3. Verbal Reporting of Results

4. Education / Certification / License

5. Adequate personnel to perform testing

6. Transcription Errors

 

4. Reviewing the Risk Assessment

a. The Risk Assessment should include all three phases of the testing process

i. Preanalytic

ii. Analytic

iii. Postanalytic

b. Determine if the current practices are sufficient to detect the sources of error or failure in your test system.

c. Determine whether the identified risks need to be monitored or controlled regularly in the testing process. (See Appendixes A & B.)

i. Probability of Harm

ii. Severity of Harm

5. Quality Control Plan

a. A Quality Control Plan (QCP) describes practices, procedures and resources needed by your laboratory to ensure the quality of a testing process.

i. Includes measures to assure the accuracy and reliability of test results and that the quality of testing is adequate for patient care.

ii. The QCP must provide for immediate detection of errors that occur due to test system failure, adverse environmental conditions and operator performance.

iii. It must monitor, over time, the accuracy and precision of test performance that may be influenced by changes in the specimen, test system, reagent, environment or variance in operator performance.

iv. A QCP must include the number, type and frequency of testing control materials, as well as criteria for acceptable quality control.

v. If indicated by the risk assessment, the QCP may also incorporate the use of:

v.1. Electronic controls

v.2. Equipment maintenance

v.3. Internal controls

v.4. Proficiency Testing

v.5. Personnel training and competency assessment

v.6. Equipment calibration

v.7. Other specified quality control activities

b. Creating a QCP

i. A complete QCP must:

1. Provide for immediate detection of errors for each phase of the testing process, pre-analytical, analytical and post-analytical.

2. Specify the number, type and frequency of testing QC material(s).

a. CAP requires external QC be performed every 31 days.

3. Contain criteria to determine acceptable QC results.

4. Require the laboratory perform QC as specified by the manufacturer’s instructions, but not less than the manufacturer’s instructions.

5. Indicate that your Laboratory Director reviewed, signed and dated the QCP document.

6. CAP forms (if applicable to facility)- List of Individualized Quality Control Plan and Individualized Quality Control Plan Summary

ii. See Appendix H to see an example of a QCP.

6. Quality Assessment (QA)

a. What is Quality Assessment?

i. Monitor and Assess

1. The laboratory must establish and follow written policies and procedures to monitor and assess, and when indicated, correct problems identified.

1.a. Monitoring should include, but is not limited to, the following risk assessment components:

1.a.i. Specimen

1.a.ii. Test System

1.a.iii. Reagents

1.a.iv. Environment

1.a.v. Testing Personnel

ii. Corrective Action

1. The QA must also include a review of the effectiveness of corrective actions taken to resolve problems identified.

b. Examples of QA activity

i. Reviewing the room temperature log sheet for problems and evidence of corrective actions.

ii. Reviewing control documents for out of range values and corrective actions taken.

iii. Reviewing personnel training records for completion of required trainings and competency assessments.

c. Documents to consider for QA assessment monitoring and review may include (but not limited to):

i. QC data sheets review

ii. Delta check logs

iii. Proficiency testing records

iv. Complaint reports

v. Patient results review

vi. Specimen recollection logs

vii. Specimen rejection or quantity not sufficient logs

viii. Panic value call logs

ix. Turnaround time reports

x. Temperature logs

xi. Records of preventive measures, corrective actions and follow-up

xii. Personnel competency records

xiii. Maintenance logs

xiv. Training logs

xv. FDA alerts

d. Corrective Actions

i. Whenever there is a testing process failure, the laboratory must conduct an investigation to identify the cause of the failure and its impact on patient care.

ii. The investigation must include:

1. Documentation of all corrections

2. Corresponding corrective action(s) for all patient results affected by the testing process failure

3. Evaluation of the effectiveness of the corrective action(s) taken

iii. The laboratory must implement the correction(s) and corresponding corrective action(s) necessary to resolve the failure and reduce the risk of recurrence in the future.

iii.1. The laboratory must update the risk assessment with the new information and modify the QCP, as needed.

Appendix A: Ranking Severity of Failure and Probability of Harm

Severity of Failure

• Negligible: Inconvenience or temporary discomfort
• Minor: Temporary injury or impairment not requiring professional medical intervention
• Serious: Injury or impairment requiring professional medical intervention
• Critical: Permanent impairment or life-threatening injury
• Catastrophic: Results in patient death

Probability of Harm

• Frequent: Once per week
• Probable: Once per month
• Occasional: Once per year
• Remote: Once every few years
• Improbable: Once in the life of the test system

Appendix B: Risk Acceptability Matrix

	Severity of Harm
Probability of Harm	Negigible	Minor	Serious	Critical	Catastrophic
Frequent	X	X	X	X	X
Probable	OK	X	X	X	X
Occasional	OK	OK	OK	X	X
Remote	OK	OK	OK	OK	X
Improbable	OK	OK	OK	OK	OK