Facility: CHRISTUS Spohn Hospital Alice
Test System: Sofia STREP A with reader
Test System Primary SOPs include: M10, M260
Historical Quality Review: Review of quality control, and proficiency testing results. Quality control parallel testing results with new lots of cartridges were reviewed New quality control lots are analyzed with the old lot before being placed in use and QC ranges were reviewed. Verification of new methods by running correlations with patient samples. Processes to mitigate patient reporting errors and delayed reports are addressed in this IQCP.

Information Used to Conduct Risk Assessment

Regulatory and Accreditation Requirements:
Checklist from Accrediting Agency: CAP All Common and Microbiology
Method verification: Rapid test system verification completed in year 2019. Documentation filed in the Laboratory Department.
Training of personnel: Completion of training documented in 2019.
Competency Assessment: New employees 6 months after initial training and annually thereafter. Documentation filed in Human Resources department in Corpus Christi.
Proficiency Testing: Rotate personnel; all personnel review results. Proficiency testing records filed in the Laboratory Department.
Quality Control: Quality Control is performed initially (Negative/Positive) and at least every 31 days, prior to implementation of new lots or new shipments, whenever there are software updates or change in instrumentation for the reader and whenever deemed necessary.
Test System Information:
Manufacturer: The package insert contains system performance data and describes testing principle and procedure, QC recommendations, and limitations. The package insert is located in the Laboratory Department. Manufacturer alerts and bulletins are located in the Laboratory Department.
References/Materials used in the Risk Assessment: Sofia Operators Manual Package insert Initial Validation Data Historical QC and PT testing Data
Summary of in-house data from routine testing of QC materials: QC testing was performed according to Policy and Procedure M260
Summary of in-house data from routine performance checks: No performance problems identified that would impact patient results.
Summary of corrected reports and physician complaints: Documentation of corrected reports located in Laboratory Department. Documentation of physician complaints located in Risk Management Department.

Risk Assessment and Determination of Risk Level

Frequency of occurrence: Unlikely (once every 2-3 years) Occasional (once per year) Probable (once per month) Frequent (once a week)	Severity of harm to patient: Negligible (temporary discomfort) Minor (temporary injury; not requiring medical intervention) Serious (impairment requiring medical intervention) Critical (life threatening consequences)
Risk Level:
Risk level for any Risk Factor that is “Not Acceptable” must be addressed in the IQCP. Risk level for any Risk Factor that is “Acceptable” may be included in the IQCP at the discretion of the Laboratory Director.

Risk Acceptability Matrix

Probability of Harm	Negligible	Minor	Serious	Critical
Frequent	Not Acceptable	Not Acceptable	Not Acceptable	Not Acceptable
Probable	Acceptable	Not Acceptable	Not Acceptable	Not Acceptable
Occasional	Acceptable	Acceptable	Acceptable	Not Acceptable
Unlikely	Acceptable	Acceptable	Acceptable	Acceptable

Risk Acceptability Assignment

Risk Factor (Possible Sources of Error)	Frequency of occurrence	Severity of harm to patient	Risk Level
Pre-analytical
Specimen (Primary):
Patient identification	Probable	serious	Not Acceptable
Collection/container/volume	Occasional	minor	Acceptable
Integrity	Occasional	minor	Acceptable
Transport	Occasional	minor	Acceptable
Clinically relevant	Probable	minor	Not Acceptable

Risk Factor (Possible Sources of Error)	Frequency of occurrence	Severity of harm to patient	Risk Level
Analytical
Testing Personnel:
Training	Occasional	minor	Acceptable
Competency	Occasional	minor	Acceptable
Experience	Occasional	minor	Acceptable
Proficiency Testing	Unlikely	negligible	Acceptable
Staffing	Occasional	minor	Acceptable
Reagents/Cartridges:
Shipping/receiving/storage	Occasional	minor	Acceptable
Expiration dates	Unlikely	minor	Acceptable
Preparation/use	Probable	minor	Not Acceptable
QC storage	Occasional	negligible	Acceptable

Environment:
Temperature/airflow/humidity/ ventilation	unlikely	negligible	Acceptable
Utilities	occasional	minor	Acceptable
Space	unlikely	negligible	Acceptable
Noise/vibration	unlikely	negligible	Acceptable
Test System:
Mechanical/electronic stability of instrument/equipment	occasional	negligible	Acceptable
Post-analytical
Test Results:
Results reported within 6 hours of order	unlikely	minor	Acceptable
Manual entry of results	probable	serious	Not Acceptable
Transmission of results to Electronic Health Record	occasional	minor	Acceptable
Review reported results	occasional	serious	Not Acceptable
Clinician feedback	occasional	serious	Not Acceptable

Risk Assessment

Possible Sources of Error	How can identified sources of error be reduced?
Risk Factor	Possible Error
Preanalytical
1: Specimen	Improper specimen procurement/ handling/processing	Adhere to procedures that address patient identification and specimen collection, labeling, transport, storage and remedial actions to control improperly handled specimens or delayed specimens in the package insert and SOP Review specimen processing errors with involved staff as soon as practical upon error identification. During initial training and competency assessment, emphasize proper specimen handling/processing
Patient/specimen identification	misidentification	See above (Specimen) Emphasis on 2 patient identifiers
Collection/container/ volume	See above (Specimen)
Integrity	See above (Specimen)
Transport	See above (Specimen)
Storage	See above (Specimen)
Analytical
2: Testing Personnel	Incompletely trained	During initial training and competency assessment, emphasize: Key aspects of Analyte testing to include those described in this IQCP Manager/Lead Technologist annually review any changes in recommendations described by accrediting agencies or standards organizations

Training	See above (Testing Personnel) Initial training and competency, assessment for new associates at 6 months and then annually thereafter
Competency	See above (Testing Personnel) Initial competency, re-assessment for new associates at 6 months and then annually thereafter
Experience	Manager / Lead Technologist monitor/assess skills related to testing, including reports and identification of values during first 90 days of employment.
Proficiency Testing	All staff participate in PT programs.
Staffing	Manager/Lead Technologist to review appropriate staffing needs for department on a daily basis and adjust as necessary.
3: Reagents	During initial training and competency assessment, emphasize: Take responsibility for reagents/supplies (all staff) Maintain test kit at proper storage conditions Check expiration dates Perform required QC
Receiving/storage	Incorrect ordering Depleted reagent supply Reagent integrity compromised	Staff member(s) inventory test kits and QC material to ensure inventory properly maintained and testing materials are handled/stored appropriately on receipt Lead Technologist to order supplies at the request of the technologist responsible for departmental inventory weekly or as needed and in sufficient quantity to assure availability and minimize waste due to expirations.
Expiration dates	See above (Reagents)
Use	Testing materials used in accordance with manufacturer’s recommendations.
QC storage	QC out of control due to improper QC materials, or technique	During initial training and competency assessment, emphasize: Potential sources of QC failures QC troubleshooting. Controls must have valid internal control as well as the appropriate result for the control material QC frequency Role of QC to ensure reliable reporting of patient results
4: Environment	Results not reported	During initial training and competency assessment, emphasize standard rules for: Take responsibility for any possible environmental problem (out of the ordinary observation)(all staff) Temperature recording daily
Temperature/airflow/ humidity/ ventilation	See above (Environment)
Utilities	See above (Environment)
Space	N/A (sufficient space available)
Noise/vibration	See above (Environment)
5: Test System	During initial training and competency assessment, emphasize standard rules for: Take responsibility for any possible test system problem (out of the ordinary observation)
Postanalytical
6: Test Results	Lead Technologist maintains summary of incorrect results released and meets with laboratory manager or director monthly to review this summary QA monitor for time to reporting results During initial training and competency assessment, emphasize: Need for timely results to guide therapy / treatment Reporting results (timely reporting)
Reading Results	Reading Results	Reader not functioning – this test cannot be resulted without reader Reading outside the approved time frame
Interpreting Results	Interpreting results	Instrument will not report if any area is invalid
Review reported results	Erroneous results reported Report comments missing or inappropriate for the specimen	See above (Test Results and Test System) Conditions listed in package insert may cause false positive results requiring confirmatory testing). SOP requires the plating of all specimens that test negative for Strep A on rapid testing kits
Clinician feedback	Complaints/suggestions regarding delayed results and potential erroneous results	See above (Test Results) Incorporate suggestions into QA plan, as appropriate.

Final QCP
Based on our risk assessment and Quality Assessment, the QCP consists of following the instructions that are provided in the Chemistry policy and procedure manual and are summarized here.
Testing of External QC levels Negative/Positive on each new kit lot/shipment before or concurrently with placing these materials into use. Internal QC run and validated with each test.
Testing QC at least every 31 days.
Recording and evaluating QC results according to QC acceptability criteria as defined in the policy and procedure manual. Any out-of-range result is immediately investigated and corrective action performed prior to releasing any patient results.

Quality Assessment: Ongoing Monitoring for QCP Effectiveness (Performed by manager and/or Lead Technologist)
Reasons for QC failures, PT failures, and patient reporting errors will be examined and addressed as needed in a new/updated risk assessment: 1) Has a new risk factor been identified? 2) Does this change the frequency of risk? 3) Does the risk factor change the potential severity of harm to patient?
Daily review of patient results for reporting errors and clinician complaints. Take corrective action and revise QCP as needed.

Monthly review of QC results by Medical Director and/or his designee, manager and/or Lead Technologist. Take corrective action and revise QCP when unexpected QC failures indicate adjustment to the QC plan defined herein is needed.
Monthly review of length of time to report critical values (should be < 1hr). Take corrective action and revise QCP when number of delayed reports exceeds acceptable limit as established by the laboratory director.
Regular review of Proficiency Testing results. Take corrective action and revise QCP if necessary when PT results are not acceptable.
Monthly review of all equipment maintenance/monitoring logs according to standard laboratory protocols. Take corrective action and revise QCP as needed.
Regular training and competency assessment according to standard laboratory protocols. Modify training and revise QCP as needed.
Continual participation in this institution’s quality program that addresses specimen handling and erroneous specimen labeling. Take corrective action and revise QCP as needed.

Prepared by: Barbara Herro, MT ASCP