An IQCP Primer from the Real World
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
Valley Health System
[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
iv. Environmental requirements
v. QC frequency
vi. Specimen Requirements
vii. Reagent storage
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
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
6. Workspace – free of clutter, dust or debris
e. Assessing PERSONNEL Risks
i. Things to consider
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
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.ii. Test System
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|