IQCP Inspector Training Scenarios

Transcription

1 Scenario 1: You are reviewing the product insert for a non-waived point of care blood gas analyzer that uses a cartridge for each patient sample to provide ph, po2 and pco2 results. The manufacturer s instructions state that the electronic control simulator may be used as a daily control, and the liquid external controls should be run upon opening each new box of reagent cartridges and every 30 days that the same box of cartridges is in use. The laboratory has an IQCP in place for these tests on this analyzer, and the quality control plan indicates that the electronic simulator will be run every 8 hours, and the external liquid control will be run upon opening each new box of cartridges. The QC records for the electronic simulator and the external controls are reviewed monthly by the point of care coordinator, who is the director s designee for this function. The checklist requirement states: COM Quality Control Plan Elements Phase II The individualized quality control plan must define all aspects monitored based on the potential errors identified during the risk assessment, including the following parameters as applicable: The number, type(external and internal quality control systems), and frequency of quality control Criteria for acceptance performance Monitoring of the testing environment and reagents Specimen quality Instrument calibration, maintenance, and function checks Training and competency of testing personnel Provisions for multiple identical devices and variation for uses covered under one IQCP NOTE: The components of the quality control plan must meet regulatory and CAP accreditation requirements and be in compliance with the manufacturer instructions and recommendations, at minimum. The quality control plan must control the quality of the test process and ensure accurate and reliable test results. External control material samples must be analyzed at least every 31 days and with new lots and shipments of reagents or more frequently if indicated in the manufacturer's instructions. Based on the information provided, what should you do regarding compliance with COM.50500? A. Cite a deficiency for not following the manufacturer s instructions. B. Provide a recommendation to perform controls every 30 days. C. Request more information. D. Move on as the laboratory is in compliance College of American Pathologists. Page 1 of 18

2 The correct answer is C Request more information. Based on the information provided, it is not clear how often a new box of cartridges is opened. If a box is used for less than 30 days, running external controls upon opening of the box would be sufficient. Review several months of QC records to confirm this. If on the other hand, the same box of cartridges is used for more than 30 days, you should cite a deficiency. The laboratory s quality control plan is not following the manufacturer s instructions, which state that external controls must be run at least every 30 days if the same box of cartridges is in use. They would also not be in compliance with the checklist requirement because external control materials are not analyzed at least every 31 days as specified in the NOTE. If the laboratory is being inspected with the 2014 edition of the checklists: CITE: COM Documented QM/QC Plan AND Appropriate discipline specific checklist requirement for daily QC Suggested language for citation: The QCP for (point of care blood gas analyzer for ph, po2 and pco2) does not follow manufacturer's instructions for quality control. The QCP indicates that external liquid control will be run upon opening each new box of cartridges. The manufacturer s instructions say at least every 30 days if the same box of cartridges is in use College of American Pathologists. Page 2 of 18

3 Scenario 2: The laboratory you are inspecting is using the same non-waived activated clotting time instrument in their point of care program that you use in your laboratory s point of care program. They have implemented an IQCP for this test, and it meets the requirements for QC as specified by the manufacturer. As you review their quality control plan, you note that based on the risk assessment they conducted, they elected to run external controls less frequently than your laboratory determined was necessary based its own risk assessment. As you review the risk assessment, you find that they did not classify the risks the same way your laboratory did, and because of this, you disagree with their conclusions and feel they need to increase the frequency of the external controls. From the records reviewed on the test performance, you did not identify any quality issues or negative patient outcomes associated with the test. You are reviewing COM to determine if the lab is in compliance: COM Risk Assessment Phase II The IQCP for a test/device/instrument includes a risk assessment to evaluate potential sources of error to include all of the following: Preanalytic, analytic and postanalytic phases of the testing process Intended medical uses of the test and impact if inaccurate results are reported (clinical risk) Components of the tests including reagents, environment, specimen, testing personnel, and test system Variations in the components based on use of the tests (e.g. use in different environments, by different personnel, or multiple identical devices) Data from the laboratory's own environment, instrument/equipment performance, and testing personnel Manufacturer's instructions and recommendations Based on the information provided, what should you do? A. Cite COM.50300, indicating their risk assessment is not adequate. B. Cite COM because then lab performs QC less frequently than your lab. C. Move on as the laboratory is in compliance College of American Pathologists. Page 3 of 18

4 The correct answer is C Move on as the laboratory is in compliance. While you may disagree with the risk assessment the laboratory performed, as long as it encompasses all five required elements (specimen, reagents, test system, testing personnel and environment) and the quality control plan has been approved by the laboratory director, the laboratory is in compliance. Because some elements of the risk assessment will vary from laboratory to laboratory (eg, testing personnel, environment, specimen), it is possible for two laboratories using the same instrument/reagent system to evaluate the severity of a given risk differently and set different quality control frequencies accordingly. Inspectors should focus on evaluating whether the laboratory s IQCP includes all the required elements. Whether the inspector agrees with a laboratory s conclusions should have no bearing on the determination of compliance with checklist requirements. This is an opportunity for an educational exchange and discussion, and an inspector could include a recommendation for modifications, but recommendations are not required and a laboratory is not obligated to implement recommendations College of American Pathologists. Page 4 of 18

5 Scenario 3: Today s date is January 12, 2016, and you are inspecting the microbiology department when you notice that the laboratory is performing weekly QC for its microbiology susceptibility testing system following the CLSI guidelines. When you request to review the laboratory s IQCP, the supervisor tells you that they are still working on the data collection for the IQCP and it should be done in about 3 weeks. When you inquire why they are not performing daily QC in the interim, she replies that they are a small public health laboratory, and it would be cost prohibitive for them to run daily QC. Since they have always followed CLSI guidelines, and validated this years ago, they decided it wasn t necessary to perform QC daily in the interim because they hadn t changed any susceptibility reagents. Based on the information provided, what should you do? A. Cite the relevant IQCP requirements found in the All Common and Microbiology checklists. B. Recommend that the laboratory complete their IQCP in less than 3 weeks. C. Move on as microbiology is not eligible for IQCP College of American Pathologists. Page 5 of 18

6 The correct answer is A Cite the relevant IQCP requirements found in the All Common and Microbiology checklists. Providing a recommendation is not appropriate as the laboratory should have been in compliance by January 1, Susceptibility test systems are eligible and do require an IQCP in order to perform QC less frequently than daily or day of use. If the laboratory is being inspected with the 2014 edition of the checklists: Cite: COM.04000: Documented QM/QC Plan MIC.21910: Susceptibility Test QC Frequency Suggested language for citation: IQCP meeting 2015 checklist requirements not implemented for (list susceptibility test(s)) College of American Pathologists. Page 6 of 18

7 Scenario 4: You are inspecting the automated chemistry department and notice that the laboratory has implemented an IQCP for their multi-channel automated instrument. As you review their quality control plan, you see that they have determined that all analytes tested on this analyzer require 2 or 3 levels of external quality control to be run daily. You note that this particular analyzer does not meet the CAP s eligibility requirement for IQCP, because it does not have any internal controls. When you bring this to the attention of the supervisor, he indicates that he is aware of this, but his director wanted IQCPs put in place throughout the laboratory. The director required all non-waived testing that did not meet IQCP eligibility to follow the CLIA-mandated QC frequency. Based on the information provided, what should you do? A. Cite a deficiency for implementing IQCP for an instrument that does not meet CAP eligibility criteria. B. Recommend that lab not refer to this as an IQCP as it is misleading. C. Move on as the laboratory is in compliance College of American Pathologists. Page 7 of 18

8 The correct answer is C Move on. While it is not necessary to implement an IQCP if the laboratory does not reduce the QC frequency to less than daily QC, it is not a reportable offense either College of American Pathologists. Page 8 of 18

9 Scenario 5: You are inspecting the microbiology department and note that they are performing weekly quality control for their Gram stains, but have not implemented an IQCP for this. MIC Gram Stain QC Phase II Quality control of Gram stain reagents is performed for intended reactivity and recorded for each new batch of stains and at least weekly against known gram-positive and gram-negative quality control organisms. Based on the information provided, what should you do? A. Cite the laboratory for COM.50500: Quality Control Plan Elements. B. Provide a recommendation to implement an IQCP. C. Move on as the laboratory is in compliance College of American Pathologists. Page 9 of 18

10 The correct answer is C Move on. Gram stains do not meet the eligibility criteria for IQCP, so they will fall under the specific quality control requirements listed in the Microbiology checklist (MIC.21540). The default CLIA requirement for Gram stains is weekly QC College of American Pathologists. Page 10 of 18

11 Scenario 6: Today s date is February 22, 2016 and you are inspecting the point of care testing at a large teaching institution. They have listed four tests for which they have implemented an IQCP on their List of Individualized Quality Control Plans form and have provided you with these IQCPs for your review. As you look through them, you note that one was not approved by the director until February 9, 2016, although it was approved by another pathologist in late December You review the quality control records for this test from January and February 2016 and find the practices are consistent with the QCP for this test and the manufacturer s requirements. When you ask the Point of Care Coordinator about the approval of the quality control plan, he explains that the director had been out on medical leave from November through the month of January. She signed the IQCP when she returned in early February. The pathologist who was the acting director during this time approved the IQCP; it is his signature with the December 2015 date. The requirement states: COM Quality Control Plan Approval Phase II The IQCP includes a written quality control plan approved by the laboratory director prior to implementation. NOTE: The quality control plan may be part of a test procedure or be a separate written plan. As an efficiency, a single plan may address multiple tests performed on one device. A separate, quality control plan approved by the laboratory director must be in place for each laboratory with a separate CAP and CLIA number. Based on the information provided, what should you do? A. Cite a deficiency as IQCP approval cannot be delegated. B. Cite a deficiency for COM but mark it corrected-onsite. C. Move on as the laboratory is in compliance College of American Pathologists. Page 11 of 18

12 The correct answer is C Move on. While it is correct that the director cannot delegate the approval of IQCPs, it is acceptable for an acting director to approve the IQCP in the absence of the director. In this case, the director acted appropriately by adding her approval when she resumed the directorship of the laboratory. Ideally, the acting director would indicate that they are approving the plan as the acting director College of American Pathologists. Page 12 of 18

13 Scenario 7: While inspecting the Immunology section, you run across an occurrence report with a physician complaint questioning the quality of results of a specific test. The physician was concerned that false positive results have been released for at least four of her patients. You recall that the Immunology section has implemented an IQCP for that test and ask for the records of the investigation. The complaint was received several months after the IQCP was implemented. The findings of the investigation consisted of a written summary which indicated: There was an error due to pipetting; the amount of diluent needed for control specimens was different than the amount needed for patient samples. The same technologist tested all of the patients in question. Retraining of the technologist involved was conducted. The laboratory did not go back and retest any patients, retrain other personnel, or have any records showing that the IQCP was reevaluated. The requirement states: COM Quality Assessment Monitoring Phase II Ongoing quality assessment monitoring is performed by the laboratory to ensure that the quality control plan is effective in mitigating the identified risks for the IQCP and includes the following: Review of quality control and instrument/equipment maintenance and function check data at least monthly Evaluation of errors relating to preanalytic, analytic and post analytic phases of the testing process Review of complaints from clinicians and other healthcare providers regarding the quality of testing to confirm the clinical efficacy of testing, and Evaluation of corrective actions taken if problems are identified Reapproval of the quality control plan by the laboratory director or designee at least annually Based on the information provided, what should you do? A. Cite a deficiency for COM B. Provide a recommendation that all staff review and retrain on pipetting procedures. C. Move on as the laboratory is incompliance by virtue of the investigation College of American Pathologists. Page 13 of 18

14 The correct answer is A-Cite a deficiency. The investigation is incomplete because it does not include: The evaluation of patient results, which was the basis of the physician complaint, The reevaluation of the risk assessment determination of dilution errors. If the laboratory is being inspected with the 2014 edition of the checklists: Cite: COM.04000: Documented QM/QC Plan Suggested language for citation: Ongoing quality assessment monitoring for (list test) is not performed as indicated by an incomplete investigation of a physician compliant and reevaluation of the risk assessment College of American Pathologists. Page 14 of 18

15 Scenario 8: You are inspecting the immunology section of the laboratory in early March 2016 and note on the IQCP Test List/Summary that an IQCP was developed for the nonwaived Influenza A/B test. A review of the procedure indicates that the laboratory is following manufacturer s instructions and has included much of this information in the risk assessment. The supervisor provides you a copy of the risk assessment that includes historical data collected over the past year. The data demonstrates the QC protocol developed has been in place for the last year and no issues related to QC or reagent storage occurred. The provided risk assessment also included information regarding the following topics: Specimen Reagents Test System Media Mixing kits Cross reactivity Poor collection Test at room temperature Test timing Transportation Expired reagents Measurements (Wrong Pipettes) Misidentified patient Storage temperature Misinterpretation of results Wrong swab type Shipping temperature Mucoid/specimen quality Mislabeled specimen Not following manufacturer s instructions Time of collection The requirement states: COM Risk Assessment Phase II The IQCP for a test/device/instrument includes a risk assessment to evaluate potential sources of error to include all of the following: Preanalytic, analytic and postanalytic phases of the testing process Intended medical uses of the test and impact if inaccurate results are reported (clinical risk) Components of the tests including reagents, environment, specimen, testing personnel, and test system Variations in the components based on use of the tests (e.g. use in different environments, by different personnel, or multiple identical devices) Data from the laboratory's own environment, instrument/equipment performance, and testing personnel Manufacturer's instructions and recommendations You explain that you will be citing a deficiency for COM because personnel and environment (required elements) are not included in the risk assessment. On your way to the Pre-summation Conference, the lab manager hands you a document signed by the lab director indicating that in the last ten years while he has been lab director there has never been an issue involving personnel or environmental factors. Based on the information provided, what should you do? A. Cite a deficiency for not including all the required elements. B. Change the deficiency to a recommendation that all elements should be included in the risk assessment. C. Recommend a review of personnel and environmental risks within 30 days. D. Remove the deficiency as there have been no issues in the past College of American Pathologists. Page 15 of 18

16 The correct answer is A Cite a deficiency. The requirement states the required elements of the risk assessment. Risks associated with personnel and environment are very specific to the laboratory and must be evaluated. If the laboratory is being inspected with the 2014 edition of the checklists: Cite: COM.04000: Documented QM/QC Plan Suggested language for citation: The risk assessment for Influenza A/B test does not contain the required elements of personnel and environment College of American Pathologists. Page 16 of 18

17 Scenario 9: You are inspecting the Microbiology section and note that they have an IQCP in place for their molecular cartridge test, which includes an internal control. The IQCP risk assessment table includes categories of risk for the specimens, test system, reagents, environment, and personnel. There is also a detailed fishbone diagram that includes: temperature, humidity, quality of air, altitude, dust, adequate space, light, electrical, compressor, water quality, and air pressure. As you look for data addressing each of these items you realize some of these do not apply to this lab. Further investigation shows that this is the sample IQCP sent from the manufacturer. There are no specifics for this laboratory. COM Risk Assessment Phase II The IQCP for a test/device/instrument includes a risk assessment to evaluate potential sources of error to include all of the following: Preanalytic, analytic and postanalytic phases of the testing process Intended medical uses of the test and impact if inaccurate results are reported (clinical risk) Components of the tests including reagents, environment, specimen, testing personnel, and test system Variations in the components based on use of the tests (e.g. use in different environments, by different personnel, or multiple identical devices) Data from the laboratory's own environment, instrument/equipment performance, and testing personnel Manufacturer's instructions and recommendations NOTE: The risk assessment must include a process to identify the sources of potential failures and errors for a testing process, and evaluate frequency and impact of those failures and sources of error. The laboratory director must consider the laboratory's clinical and legal responsibilities for providing accurate and reliable patient test results. Published data and information may be used to supplement the risk assessment, but is not a substitute for the laboratory's own studies and evaluation. The laboratory must involve a representative sample of testing personnel in the process of conducting the risk assessment. It is not necessary for all personnel to be involved. The risk assessment for laboratories with multiple identical devices must show that an evaluation was performed if there are differences in testing personnel or environments where testing is performed, with customization of the quality control plan, as needed. The QC study performed to assess the performance and stability of the tests must support the QC frequency and elements defined in the laboratory's quality control plan. The study must include data representing, at a minimum the maximum interval between runs of external quality control. The laboratory may use historical data during the risk assessment for tests already in place. For affiliated laboratories (e.g. systems) with integrated procedures, each accredited laboratory must have its own IQCP approved by the laboratory director. There must be records demonstrating that risks specific to the site were evaluated involving a representative sample of local testing personnel to conduct the risk assessment and that laboratory-specific QC data were used in the study to support the defined frequency of quality control. Laboratories may use data from other sites to supplement risk assessments and to support their findings. Based on the information provided, what should you do? A. Cite a deficiency for not including lab-specific data. B. Cite a deficiency but mark it corrected-onsite if the evaluation is completed within 30 days. C. Move on as IQCP is just being introduced and the laboratory does have something in place College of American Pathologists. Page 17 of 18

18 The correct answer is A Cite a deficiency. The risk assessment and subsequent quality control plan must reflect laboratory specific risks (environment and personnel). The entire IQCP must be approved and implemented prior to reducing the frequency of QC. If the laboratory is being inspected with the 2014 edition of the checklists: Cite: COM.04000: Documented QM/QC Plan Suggested language for citation: The risk assessment for molecular cartridge test in Microbiology did not include the laboratory's own studies and evaluation (only used information provided by the manufacturer). The laboratory did not involve a representative sample of testing personnel in the process of conducting the risk assessment College of American Pathologists. Page 18 of 18