The following questions were asked
during two recent Siemens sponsored webinar entitled: IQCP: You Are
More Ready Than You Know and Goodbye EQC, Hello Individualized
Quality Control: Will you be Ready for Inspection? In
an ongoing effort to serve the the educational needs of the laboratory
and point of care communities, Siemens experts have organized and
responded to our participants questions to help ensure that everyone has
a clearer understanding of the subject matter. Additional Resources:
For further information on CLSI's EP23, visit: www.clsi.org.
Download a copy of Siemens' white paper on blood gas automatic quality control here.
Register for upcoming Siemens sponsored webinars and view archived sessions here.
A: The table was formulated for the average lab. While many labs are aware of ISO and may use the concept, it is not a general requirement for most. However, you may choose to add the column to your IQCP Risk Assessment table. Remember IQCP is flexible for your needs. Examples given were those based on the EP-23 document and average lab or lab testing environment.
Q: Do you have a system in place to ensure the immediate detection of errors that occur due to test system failure, adverse environmental conditions and operator performance?
A: This would be dependent on the test system and culture itself. For example, in POCT on the Ambulances, going out into the 90+ F or 0F or below, the POCT devices are set to warn or extreme temperature and do not function below the manufacturer's determined breakpoint.
Q: Is IQCP mandatory, if not will it be in the future?
A: Like EQC, IQCP in not mandatory. It is an optional quality plan. As to the question of its future; we anticipate regulatory agencies to incorporate it into their requirements, but only time will tell.
Q: Isn't IQCP only required for waived POC testing? I thought you were initially performing the UA via dipstick. Why did you develop an IQCP process for this test?
A: Remember IQCP is about mitigating risk as part of an overall quality assurance plan. As more risks live in POCT than the Lab, why wouldn't it be good practice to review the process and design a better, safer process? IQCP is not a requirement for any testing system or complexity. It is an optional quality management plan used to mitigate the risk of inaccurate patient results.
Q: Do any of the presenters know if this is being adopted into the CAP checklist, and if so, when?
A: As of October 1, 2013, CAP, TJC and COLA have no specific dates or directions on IQCP related changes. They all recommend maintaining your current requirements and monitoring updates for those pertaining to IQCP.
Q: Does the RAPIDComm interface with the iSTAT?
A: RAPIDComm is currently Siemens specific and connects our Blood Gas, Urinalysis and Diabetes POC devices.
Q: I am in a unique situation in my laboratory. We are a COLA accredited independent laboratory, CLIA Certificate of Accreditation. We use an automated system for the Macroscopic UA in our laboratory. Do I need to implement IQCP?
A: IQCP is entirely optional.
Q: Is an IQCP required for all laboratory testing, or only for those situations where you would like to extend the performance of QC beyond the standard (e.g., every 24 hours or every run, or every 8 hours for QC)?
A: After reviewing your complete process and test, if you would be modifying your quality control or process to something new, you may choose to develop an IQCP. You may also choose to stay with the manufacturer's recommendations and process instructions and not develop an IQCP.
Q: Is this only for POC?
A: No. IQCP may be employed for any testing process or system in any laboratory test environment (remember POCT is by definition a laboratory test).
Q: Do we have to perform risk assessment to all analytes tested within all stages, pre analytical, analytical and post analytical or we may just group the assessment within areas?
A: If an IQCP is intended to mitigate risk by providing a flexible frame work, this is up to those crafting the IQCP. You may choose to tackle the whole process from order placement to storage of the tested specimen, or the portion within your control. that's the beauty of IQCP; you determine what to address.
Q: It seems that the best overall option for IQCP is to work with an informatics system. This is also very expensive. How would you explain a POC test to meet IQCP without an informatics portion? For an example a POC INR test.
A: While informatics can assist with some tasks, it is never a complete solution. Where informatics is not an option because of funding or process step, review your manufacturer's information, reach out to your peers on blogs, boards and groups. They can provide some great unique and ingenious solutions. AACC and LinkedIn have great POCT boards to find "free" advice and options.
Q: Is there a specific format that the IQCP should be captured? such as in the Lean format or typical procedure format?
A: At this time there is only the CLSI EP-23 guideline document and the one here to guide us. So the answer of today is likely to transform with time. A Procedure will demand specific action and activity, which is not the IQCP focus. The IQCP focus is the guide the process toward less risk of inaccurate test results, so I would suggest more the lean documentation format. Like lean, you are remove or revising to improve safety, timing and output.
Q: If we are setting up individualized plans can we accept competency documents from agency RNs as long as that is what our policy states or do we need to do on facility competencies?
A: This is really an organizational and regulatory agency question. Food for thought: as a competency is intended to assure that the person performing laboratory testing understands the technical and organizational requirements as will as demonstrate correct operation of the test, how could an agency outside your organization assure this is met?
Q: Your example of IQCP (you showed it briefly on screen), was it a high level plan that would act as your guide as you develop specific IQCP plans per instrument type?
A: Yes. An IQCP is a high level document on how a process, test, or instrument use has been evaluated, what risks were identified and how those risks will be mitigated. Unlike a policy or procedure, it does not define the granular details of the risk mitigation practice. For example, we determined we would use PEP for operator management, but did not specify what education an RN would receive, or what education a Lab Assistant would receive.
Q: When E-QC is used is it referring to equivalent QC or electronic QC or both?
A: In the statement that EQC will be phased out, this refers to Equivalent QC. Electronic QC, or eQC, may be is a piece of the quality process or manufacturer's recommendation to consider when crafting an IQCP.
Q: What are your thoughts on six-sigma approach to decide the extent of risk per Analyte?
A: Well, I'm always in favor of looking for a six-sigma solution to risk. I would just recommend you consider if your organization's culture and practice can meet that level of process change and control. Remember, IQCP is an option, not a mandate.
Q: CMS is requiring 'in house' data to support your QC frequency under IQCP. In the case of setting up a new test without historical data, what would you recommend for minimum data collection? Would the 20 data points in parallel with patient testing required under EQC cover the need?
A: As this is a new process and/or test with no history, there would be little data to define where to mitigate risk. In the case of a new test, analyte, instrument or process, I would recommend collecting no less than 90 days worth of data once the new thing is in live and active use. The greatest risks happen once things are in their routine use and the original "should" have morphed into what "works". Remember this is where some of the greatest risks live. As new regulatory requirements are provided, this may become definitively answered, as in the case of EQC. Please review the recent CMS IQCP information publication and any additional applicable requirements.
Q: I thought IQCP did not apply to waived testing.
A: IQCP is for labs performing nonwaived testing. The IQCP concept is applicable to any laboratory testing with a risk of inaccurate test results. We looked a manual (waived) urine dipstick process and determined there was risk. The ultimate result was the change from waived to moderate complexity processes. Waived testing does have fixed requirements, but the IQCP concept is applicable to anything you would seek to mitigate the risk of reporting inaccurate results.
Q: Ginger is implying that manufacturer's minimum requirements can be superseded under an IQCP. Isn't the manufacturer's operating requirement the minimum required? Even under IQCP?
A: Please review all applicable regulatory requirements, including the CMS resources found at: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html. The focus is flexibility as long as the Lab can demonstrate mitigated risk to inaccurate results being reported within its applicable regulatory requirements.
Q: Isn't IQCP only required for waived POC testing? I thought your were initially performing the UA via dipstick. Why did you develop an IQCP process for this test?
A: IQCP is for labs performing nonwaived testing. The IQCP concept is applicable to any laboratory testing with a risk of inaccurate test results. We looked a manual (waived) urine dipstick process and determined there was risk. The ultimate result was the change from waived to moderate complexity processes. But in truth IQCP does not specifically apply to anything. Its use is at the Lab's discretion.
Q: EQC is performed on the I-Stats every 8 hours and Wet QC is performed on these analytes(CG8 and ACT's) once every month, with the implementation of IQCP, would I have to perform Wet QC every day the analyzer is used?
A: This would be up to your IQCP and regulatory agency requirements. This brings up a very important point. Doing an IQCP does not guarantee you will do less QC. You may find the best way to mitigate risk is do more QC.
Q: How do these PEP systems address the required "observation" competency assessment methods of the CAP regulations?
A: Siemens Personalized Education Plan (PEP) contains 3 focus areas (Knowledge, Skill and Ability). When accessing the Ability aspect of a device operator, PEP has the functionality to record the mentor sign-off. To learn more about PEP, please visit the following website - http://www.usa.siemens.com/PEP
Q: Is IQCP an all or nothing? Can one part of the lab have IQCP and another have standard, or by test?
A: IQCP can be applied to any portion of a process or testing system. It is flexible and up to the Lab to determine where risk are mitigated and how the IQCP is to be crafted within its applicable regulatory requirements.
Q: I also noticed that for the urine sample, that QC was going to be done daily or each day of use, why is an IQCP needed, if you are following default QC.
A: IQCP is not needed on anything. It is an option. Food for though: how can you assure that QC is performed daily/day of use before patient testing? Do you run the risk of the system being out of control and results being reported before it is discovered?
Q: After all of your information is combined and neatly placed in report form, where is the best place to keep this information? All together in one folder (either physical or virtual) or with the policy and procedure?
A: This would be up to your document control policy and practice. I keep this in both electronic and paper form. The paper form resides in its own folder with other operational data. The e-copy can be accessed from any organization location when with an inspector/surveyor.
Q: With regards to UA dipstick- if the solution is to go to automation, what happens if the instrument is down? Can staff read strips visually or would they need to prove through a competency that they are also capable of reading test visually
A: Yet another risk to mitigate! In your IQCP you would determine what the solution would be based of the risk of the occurrence and length of downtime. Personally, I have a back-up instrument bank, so we don’t do visual reading unless we are in a disaster and there is no electricity.
Q: Does this apply to tests other than POC?
A: IQCP concepts may be employed for any testing process or system in any laboratory test environment (remember POCT is by definition a laboratory test). The focus in improving the quality through risk mitigation. Consult your applicable regulatory requirement to determine limitations applicable to your laboratory.
Q: Do you have a way to detect or prevent badge sharing?
A: Oh I wish! I'm waiting for the fingerprint scanner. I have tried a few different additional process steps, like the badge is scanned and then the operator must enter their DOB except if someone is willing to risk being responsible for testing other did, they will share the personal data too. If you ever find a way to do this, please let the whole POCT community know!
Q: Will TJC be asking for a formal written IQCP for all POC tests being performed at hospitals and clinics?
A: I can't answer this question at this time. As of October 1, 2013, CAP, TJC and COLA have no specific dates or directions on IQCP related changes. They all recommend maintaining your current requirements and monitoring updates for those pertaining to IQCP. Until then, CMS has recently published the following to guide you through their requirements: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html
Q: CAP has deemed status for CLIA in many Laboratories. Is CAP considering incorporating IQCP into their inspection checklists?
A: Yes, as are all the regulatory agencies. However the dates that the requirement or checklists will be revised has not been determined as of October 1, 2013.
Q: Is it a good idea to send all Glucose results to Patient's chart? (Repeated tests)
A: This is up your organization's Medical Executive Committee and applicable regulatory requirements. Some feel it is only relevant to see the last one when a repeat occurs, others want to see everything. I would take the decision to your lab's Medical Director and then on to your organization's Medical Executive group for determination.
Q: All the info I have seen about IQCP has pertained to quantitative (or semi-quant like urine dipstick today) methods. How does IQCP pertain to immunological, qualitative tests, such as for pregnancy or Strep?
A: IQCP is not required, but its concepts can be applied to any test or process. It is an option. Food for thought: how can you assure that QC is performed as prescribed? Do you run the risk of the system being out of control and results being reported before it is discovered?
Q: Is IQCP only applicable to waived or non-waived testing?
A: IQCP concepts can be applicable to any test or process in the whole of laboratory testing. Its focus is mitigating the risk of reporting inaccurate results. Recently CMS published the following to clarify specific requirement http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html, which defines a formal IQCP as applicable to nonwaived tests.
Q: Can we still incorporate onboard AutoQC in the IQCP program for the blood gas analyzers? Will the manufacturers provide guidelines for their analyzers for the IQCP?
A: The great thing about IQCP is it makes use of all tools, processes and practices you have available to you to manage the risk of reporting inaccurate results. What I do not expect to see is a manufacture providing an IQCP recommendation for a test or instrument. Remember this is "individualized" for your individual site or organization based on your applicable regulatory requirements.
Q: Is Rapid Comm vendor neutral or only Siemens POC devices?
A: RAPIDComm is currently Siemens specific and connects our Blood Gas, Urinalysis and Diabetes POC devices.
Q: Are there any exclusions for utilizing the IQCP option related to specialties or subspecialties?
A: The formal IQCP is directed toward general clinical laboratory and laboratory testing environments. This is not intended for Pathology and its subspecialties at this time. However, the IQCP risk mitigation concept may be applied to any test or process. The focus in improving quality through mitigation of risk to report inaccurate results. For specific requirement, please review your regulatory agency's requirements and the CMS resource http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html
Q: I have a question....will IQCP be for both non-waived and waived tests?
A: IQCP concepts can be applicable to any test or process in the whole of laboratory testing. Its focus is mitigating the risk of reporting inaccurate results. Recently CMS published the following to clarify specific requirement http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html, which defines a formal IQCP as applicable to nonwaived tests.
A: No, because there are no CLIA QC requirements for Waived testing. EP23 applies to ALL non-waived testing (moderately and highly complex).
The EP23 process can be applied to any and all diagnostic testing. However, CMS does not require specific QC for waived testing and only uses EP23 as the approved guidance for developing an IQCP for non-waived testing. EP23 is applicable to all types of non-waived testing whether in a POC environment or in a large clinical laboratory. EP23 provides the CMS approved pathway for any site performing non-waived testing to use an Individualized QC plan as an alternative to the CLIA mandated minimum QC requirements. EP23 will replace the EQC options as described in the Jan. 2004 update of Appendix C of the State Operations Manual.
Q: Does the EP23-A standard state that this does not apply to Waived tests?
A: There is no such statement in EP23. EP23 describes a process that can be applied to all types of diagnostic testing. However, CMS does not require specific QC for waived testing, so, as far as CLIA compliance is concerned, EP23 is only used to develop an IQCP for non-waived testing.
Q: Will there be standardization on which tests could potentially qualify for EP23? i.e. serum HCG testing, ESR, mod complex kits for RSV or RF, etc?
A: The “standardization” already exists. EP23 does not apply to any waived testing and EP23 applies to ALL non-waived testing (moderately and highly complex).
A: If your laboratory QC plan follows the original 1992 CLIA mandated minimum QC requirements, then no further action is necessary. If the laboratory wants to use any other type of approach to QC other than the CLIA minimum, then EP23 is the CMS approved approach to validate and document the individualized QC plan.
Technically, the EP23 process needs to be applied to each analyte. However, when using a multi-analyte analyzer with a large menu, the same QC process can be applied to all analytes on the system provided none of the analytes had special analyte specific requirements. A single EP23 based QC plan can be applied as long as the plan indicates that all analytes were reviewed for any analyte specific needs.
Q: Is it expected that labs will do risk assessment and mitigation for all analytes on instruments?
A: If the laboratory wants to use a QC protocol other than the CLIA mandated minimum for any analytes, then it needs to use the EP23 process to validate the proposed QC plan for all the analytes on which it will be used.
Q: Does EP23 specifically state that liquid QC needs to be run daily for non-waived POC testing?
A: No, EP23 does NOT require any specific type of QC practice. Instead it provides a process by which ANY proposed QC plan or process can be evaluated and documented to show it effectively manages risk and thereby meets all regulatory requirements. It is entirely possible to have a CLIA acceptable, EP23 documented QC plan that does not use any “liquid QC” provided the laboratory can show risk is effectively managed.
Q: Is the manufacturer going to give us an outline of an IQCP for a given platform? The risk assessment is really subjective.
A: Since the medical use of the test result, the testing environment, the skills and experience of the individuals performing the testing, and the parts of the testing process not associated with a particular test system (i.e. specimen collection and transport, etc.) can vary significantly between testing sites, it is not possible for a manufacturer to provide a QC plan. The operation of the test system (on which the manufacturer can provide information) is only one part of the QC plan. Further, any specific IQCP provide by a manufacturer would be viewed by the FDA as a product claim and FDA is not prepared to review and approve QC plans, so such a claim is not allowed.
Risk assessment is, at some level, subjective, but has proven to be a useful tool for decades once individuals using it have gained experience with the approach and the tools.
Q: Isn't "severity of harm" purely subjective?
A: By its very nature, evaluation of risk will always be somewhat subjective. However, these techniques and tools have been used for decades by folks who design and develop medical equipment, aircraft, spacecraft, and other devices that need to function effectively and reliably. The tools and techniques of risk assessment and risk management have proven themselves to be effective. Like any other tool, it takes some education and practice to become proficient in their use.
Q: Are there criteria for effective or adequate IQCPs?
A: The criteria for an effective IQCP will be: Were all clinically significant failure modes for the testing process identified and reviewed and were all identified risks for inaccurate patient results mitigated to the degree practical.
Q: If two levels per 24 hours are not run can labs still use manufacturers’ requirements if they are less than 2-levels per 24 hours??
A: As discussed in question 7, manufacturers cannot provide specific QC protocols that are deemed CLIA/CMS acceptable with no further evaluation by the laboratory. If a testing site wants to perform QC in any way other than the CLIA mandated minimum QC, they will have to use the EP23 process to document that the QC plan effectively manages risk. That a manufacturer recommended the specific QC plan is NOT adequate proof of effectiveness.
Q: If you have multiple handheld devices, would you have to run liquid on every device each time you require QC or just a sampling of devices?
A: Within the context of EP23, if it can be documented in the EP23 evaluation of the testing process that risks for ALL testing devices are effectively managed by testing external QC on a representative device, then that practice would be acceptable. However, there would have to be adequate documentation showing how testing QC on one device validates the performance of the other devices.
Q: Will there be any forms or templates published to help labs work through the process of developing an IQCP?
A: CLSI has an EP23Workbook and an EP23 Checklist already published and available from them to assist with the EP23 process. The workbook and checklist are expressly designed for use by POC testing sites performing non-waived testing. You can purchase these documents here: http://shopping.netsuite.com/clsi. Remember, your hospital may already subscribe to a CLSI master account, so you may want to check there first to see if you already have access to the documents necessary.
A: Probably, since COLA accreditation is accepted by CMS as meeting CLIA requirements, then EP23 will have to be part of COLA’s accreditation process going forward.
Q: How will IQCP impact CAP and Joint Commission inspections? It seems like IQCP is subjective in nature.
A: Details for how CAP and the Joint Commission will handle EP23 have not been made public by either organization. Since they both must be in compliance with CLIA, they will need to incorporate EP23 into their programs. IQCP’s are no more subjective than some requirements already present in laboratory accreditation and inspection.
Q: How are surveyors going to veiw IQCP from two labs 50 miles apart using same method, but have arrived at a different QC frequency?
A: The KEY concept to EP23 is that each laboratory has different needs. In the cited example the testing volumes could be substantially different, which would impact the IQCP. The details of how samples are managed, tests performed, results reported and used will all vary somewhat between labs. Consequently, it is entirely possible and reasonable that two laboratories using the same testing system with the same menu will have different IQCPs. The testing system used and the menu are only two of many factors that go into developing an IQCP. The key will be whether or not the documentation developed during the EP23 process shows that clinically significant failure modes were identified and evaluated and that the IQCP effectively manages the identified risks.
A: While the acronym “EQC” has been used for way too many things, within the context of this presentation EQC means Equivalent Quality Control as defined by CMS in the Jan. 2004 edition of Appendix C of the State Operations Manual.
Q: It sounds like EP22 was a means for manufacturer's to list and format the specific information health care facilities are going to be asking for anyway as they formulate their own plan. So why was the decision to adopt EP22 reversed?
A: EP22 was never fully written, so it never got to the point of being considered for adoption. No decision was reversed. The committee who wrote and developed the document (the folks who knew it best) decided that the document would be unworkable and of little use to the laboratory. At the time the committee decided to stop working on the document, the proposed document would have been so large in order to anticipate all possible questions that no one in the laboratory would have readily been able to find the needed information and the manufacturers would have found it impractical to keep the proposed document up to date.
The alternative incorporated into EP23 was for laboratories to perform their local risk assessments and determine the specific information they needed. Then they would review the information from the manufacturer they already had (operators manual, instructions for use, etc.). If additional information was needed beyond what had already been supplied, the laboratory would contact the manufacturer. In this way both the laboratory and the manufacturer could focus only on what information was really needed, which would minimize effort by both parties. Over time, as it becomes apparent what the key information is, manufacturers will likely put it together and have it readily available on request.
Q: Is there a new CLSI EP23 update coming up for publishing soon?
A: Typically CLSI documents are reviewed and updated on a 5 year cycle. Since EP23 was published in 2011, the earliest it will likely be reviewed will be in 2016 and an update, if deemed necessary, would likely be published 1 – 2 years after the review.
Q: Does the AQC for the Siemens RAPIDPoint analyzers qualify as CLIA acceptable QC if run every 8 hours?
A: If the Automatic Quality Control function on the RAPIDPoint systems are scheduled to meet the number of QC levels required for blood gas testing, then yes, this would achieve the minimum requirements for CLIA- however, many laboratories are inspected by third-party accreditation organizations like CAP, Joint Commission, and COLA, and each of these inspection agencies have their own interpretation of the minimum requirement for QC. In the case of blood gas analyzers, in 2009, the Joint Commission required external liquid quality control for these systems, and consequently had stated their own interpretation of the minimum requirements of CLIA. The argument for requiring external liquid quality control was to make sure all aspects of running a sample were evaluated in the quality control process, including the operator loading a sample onto the device.