IQCP Education for Laboratory Directors & Technical Consultants: How the leaders of the laboratory must be the leaders on IQCP

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IQCP Education for Laboratory Directors & Technical Consultants:

How the leaders of the laboratory must be the leaders on IQCP

 

By Maria Hardy, IMA (ASCP)

 

 

What do LD’s and TC’s need to know?

 

IQCP is Quality Control based on Risk Management. LD’s and TC’s will be held responsible for reviewing the information available and ensuring testing personnel not only understand the concepts, but receive training and are deemed competent as well. Education on IQCP can come in many forms. Online courses, workshops, and webinars are some of the most popular forms of learning in a lab culture that is always pressed for time. In considering what to focus on as a topic of choice, two key concepts must be explored -- Quality Control and Risk Management.

 

More than the presence of a positive and negative reaction on a test strip, Quality Control (QC) is the continual review and assessment of laboratory activities. The ISO 9000 definition of Quality Control is “part of quality management focused on fulfilling quality requirements.”[1] CMS states that “QC consists of the procedures used to detect errors that occur due to test system failure, adverse environmental conditions and variance in operator performance, as well as the monitoring of the accuracy and precision of the test performance over time.”[2] The concept of QC as it relates to IQCP is to consider QC concepts as well as implementation. Concepts must be identified in the three phases of testing -- pre-analytic, analytic and post-analytic.   If you are starting to think that all of this may be “too technical” for your testing personnel, remember that it is the technical aspects of QC that makes it essential to lab quality.

 

Most people think of Risk Management in terms of insurance and business. In laboratory science, Risk Management seeks out errors with the potential to cause human harm. Risk Management is defined in ISO 14971 and referenced by CMS as the “systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling and monitoring risk.”[3] Risk Management consists of identifying, evaluating, and controlling the risk of these potential errors through a variety of quality control measures that become your IQCP.[4]  IQCP is intended to identify potential sources of error in test systems that may cause harm to the patient. The laboratory must then assess if they can manage these risks or must find ways to mitigate them.

 

Where can information or educational materials be found?

 

The Centers for Medicare & Medicaid Services (CMS) website has information on IQCP

ranging from the letters to Laboratory Directors and Surveyors to downloadable brochures. [5] CMS hosted a MLN Connects™ National Provider Call on the topic of “Individualized Quality Control Plan for CLIA Laboratory Non-Waived Testing”.[6]  CMS representatives also have worked with educational providers such as COLA Resources Inc. (which offers a comprehensive IQCP Platform[7] ) to host workshops on how to follow ICQP guidelines.

 

CMS also requires that a representative sample of the labs’ testing personnel should be involved in the risk assessment process. This is important for Laboratory Directors and Technical Consultants to note. Testing personnel should be considered in all phases of performing the Risk Assessment and creating the IQCP.

 

When to begin and what are the key components?

 

Many laboratories may think that the next 12-15 months gives them plenty of time to get ready for IQCP. This is rarely the case when implementing a new regulatory guideline that requires the collaboration and involvement of many departments and personnel. To ensure compliance on January 1, 2016, your testing personnel must be well versed in the Interpretive Guidelines and also prepared with the supporting documentation. As an LD, if you currently use EQC, you should have your risk assessment and resulting QC Plan completed, approved, and EQC eliminated prior to January 1, 2016.

 

The CMS Survey and Certification Group Letter dated August 16, 2013 states the following regarding the Laboratory Director’s additional responsibilities:  “The laboratory director must consider the laboratory’s clinical and legal responsibility for providing accurate and reliable patient test results (§493.1407 or§493.1445) prior to implementing a QCP that is less stringent than the specified Analytic Systems control regulations listed in Table1, Eligibility for IQCP.”  The Laboratory Director must review their test menu and determine if their test systems are eligible for IQCP and, if so, create a Quality Control Plan that meets these requirements.

 

The Laboratory Director should be aware that the CMS and/or Accrediting Organization Surveyor must specifically review the following areas of the IQCP for compliance[8]:

•The Risk Assessment (RA) must address all 5 required components: specimen, environment, reagent, test system, and testing personnel

• The RA must cover the 3 phases of testing: preanalytic, analytic, and post

analytic

•The RA must include in-house data, established by the laboratory and by its own personnel

•The quality control plan (QCP) must be approved, signed, and dated by the laboratory director

• The quality assessment (QA) program must include a review system for the ongoing monitoring of IQCP effectiveness

 

“Lastly, the laboratory director may assign, in writing, specific duties for the IQCP to

qualified individuals in the laboratory but is still responsible overall for the entire testing

process,” states the CMS Letter’s FAQ’s.[9]  LD’s can enlist Technical Consultants to create an IQCP. TC’s may review the existing QCP, perform the risk assessment of test systems and draft the final IQCP. The Laboratory Director will still be responsible for reviewing, approving and signing off on the final document for implementation. TC’s can then assist by updating SOP’s, training staff and performing and documenting Competency Assessments.

 

LD’s have a task to ensure the quality of not only the samples that are processed through the laboratory, but also the quality of the testing personnel they employ. Share this information with your testing personnel and invite them to research how IQCP will be relevant in your laboratory. As a LD or TC, ensure that your staff has a fundamental understanding of these concepts and terms. Then the laboratory team will be well on its way to understanding and successfully implementing IQCP.

 

Maria S. Hardy is the Technical Writer for COLA’s Education subsidiary, COLA Resources, Inc. (CRI®), a leader in online continuing education for physicians, laboratory personnel and allied health professionals.  CRI® offers continuing education through online courses, informational products in both electronic and hard copy form, webinars and workshops on cutting-edge technology and regulatory issues such as IQCP, and annual CRI® Symposia for Clinical Laboratories and Workshops, providing live educational sessions and interactive seminars with leading industry organizations. For more information, visit their website at www.criedu.org, or call 1-800-981-9883.

 

 

[1] International Standards Organization. Quality management systems – Fundamentals and vocabulary. ISO 9000. Geneva, Switzerland: International Organization for Standardization; 2005.

 

[2] Clinical Laboratory Improvement Amendments (CLIA) Equivalent Quality Control Procedures Brochure #4 (2013) http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/6066bk.pdf last accessed October 2013

[3] International Standards Organization. Medical devices – Application of risk management to medical devices. ISO 14971. Geneva, Switzerland: International Organization for Standardization; 2007

 

[4], 7 CRI IQCP Implementation Guide (2013) Columbia, Maryland.

[5] Individualized Quality Control Plan (IQCP) http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html

[6] MLN Connects National Provider Calls 2014-05-19 http://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2014-05-19-CLIA.html?DLPage=1&DLSort=0&DLSortDir=descending

 

[8] Attachment 3: LETTER FOR CoC LABORATORIES WHICH HAVE ALREADY IMPLEMENTED IQCP http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-54.pdf

[9] Attachment 5:FAQs for IQCP http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-54.pdf