Preparation Strategies for Regulatory Inspections


May-June 2013 - Vol.2 No. 3 - Page #2

Q&A with Jennifer Rhamy, MBA, 
MA, MT(ASCP)SBB, HP
Executive Director, Laboratory 
Accreditation, The Joint Commission


Medical Lab Management: What are the most important Joint Commission standards related to compliance with CLIA certificates and proficiency testing? 
Jennifer Rhamy: Although every standard relating to CLIA compliance is important, one area of particular impact (and the subject of recent headlines) is proficiency testing (PT) referral. While the regulations require the laboratory to handle a PT sample in the same manner as it would a patient sample, the PT sample cannot be sent to another lab for confirmatory or reflex testing even if that is the standard practice defined in the lab’s policies and procedures for patient samples. To properly manage PT samples, the laboratory director should make sure measures are in place to ensure that handling of PT samples terminates with the testing performed within your laboratory’s specific CLIA number. 

Another common issue occurs in facilities that handle PT acquisition and distribution through a centralized purchasing entity. Each CLIA number represents a separate lab by regulation, and each lab is expected to manage their PT within the confines of that CLIA number. In a centralized system, a PT sample intended for one CLIA number may sometimes be delivered to a different lab with its own CLIA number in the same facility or health care system. To prevent this, always verify that your PT sample box has the correct CLIA number before testing, especially if the lab has recently moved. Also, for facilities that have multiple labs with individual CLIA numbers, make sure the materials receiving staff can properly identify the correct delivery route for each PT sample box. 

MLM: If a lab’s proficiency testing is deemed unsatisfactory, what opportunities does the lab have to gain compliance?
Rhamy: Often, unsatisfactory PT is an underused opportunity to identify risks in laboratory processes. The predominant reason The Joint Commission scores unsatisfactory events during a survey is to bring attention to the fact that there is a potential need for process improvement. If a PT event is unsatisfactory, a thorough root cause analysis should always be performed and documented. In doing so, the laboratory director must seek to understand why a result was out of range, because such findings could be an indicator that the lab’s patient testing results are suspect or there is a flaw in the handling process. While clerical errors are the most common causes of both unsatisfactory and unsuccessful PT results, analytical errors do occur as well.

Clerical Errors
Never automatically dismiss a failed PT result as simply a clerical error, because the failure may also indicate a larger system error. For example, if a staff member mixed up the sample (a common clerical error), such a mistake could be a sign of inattention and the need for remedial training. It also could be a sign that the systems and processes for receiving the samples and reviewing results need revamping. If the error occurred during the submission process, then it may be worth considering a paperless submission system such as those offered by the American Proficiency Institute (API), the College of American Pathologists (CAP), and the American Association of Bioanalysts (AAB), among others.

Analytic Errors 
Laboratories often will assign the cause of an analytic error as random without sufficient investigation. Random error should  only be concluded after all other causes are ruled out. Just because your daily QC is in line does not mean you are not experiencing some kind of a trending shift wherein your results are still within the acceptable range of variation, but are trending to the tail end of your testing analyte or instrument bell curve. Consequently, you may be routinely reading everything too high or low depending on the end of the bell curve. In some cases, this could cause an erroneous patient result. Therefore, when an analytical error occurs, this is a good opportunity to thoroughly check your calibration verification, as it may be time to perform it again. 

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MLM: Is it required or recommended to notify The Joint Commission of unsatisfactory performance or unsuccessful status in proficiency testing?
Rhamy: We do not require notification for either unsatisfactory or unsuccessful proficiency testing. Unsatisfactory PT will be reviewed during the on-site survey. For unsuccessful PT, the provider notifies CMS, and The Joint Commission obtains that information directly from CMS for accredited labs. This raises an important point, though, of the distinction between an unsatisfactory result and an unsuccessful result. Periodic unsatisfactory PT results are to be expected, and while these events are reported and reviewed during a Joint Commission survey, an unsuccessful PT result (ie, failure of two out of two or three consecutive events) is more serious. By federal regulation, these events require the lab to establish a corrective action plan and a series of remediation activities in conjunction with your accreditation organization. 

MLM: How long should the lab retain proficiency testing records and what should those records consist of?
Rhamy: The laboratory should retain all PT records for a minimum of two years. These records should consist of test handling, preparation, processing, examination, reporting results, the signed attestation statement, and feedback reports. It is worth noting that The Joint Commission recommends retaining records for five years to monitor trends, but this is not required to support PT monitoring activities.

MLM: How does waived testing differ from non-waived testing in terms of standards compliance challenges?
Rhamy: Waived testing is not covered within the CLIA regulations except for the requirements to obtain a Certificate of Waiver, to follow manufacturer’s instructions, and enforcement of proficiency testing referral. The Joint Commission has standards that are common throughout our clinical programs, including the laboratory accreditation program, that define our expectations for this testing type. Following are some of the specific requirements of The Joint Commission:

  • Two out of four waived testing competency methods should be used to assess personnel performing waived testing. 
  • There are no PT requirements for waived testing. 
  • There are no minimum educational qualifications specified for waived testing direction, supervision, or performance and no supporting qualification documents are required unless required by internal policy. 

MLM: Is it necessary to use all six methods of competency assessment specified in the CLIA regulations for every non-waived test?
Rhamy: Yes it is, and for this purpose, the term test is defined as a testing platform. All six methods should be used whenever applicable (see Figure 1). There are a small number of tests that do not have instrumentation to calibrate and maintain such as manual CBCs or PPMP. Accordingly, the laboratory should document which methods are not applicable; never leave the documentation blank. 
For non-waived testing, competency should be performed before testing is performed, semiannually during the first year of employment, and annually thereafter. For waived testing, competency should be assessed, performed, and documented after orientation, at a minimum, and annually thereafter. 

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MLM: What is new this year that laboratory managers should be aware of for Joint Commission surveys?
Rhamy: Among the significant changes to Joint Commission surveys this year is the introduction of Lab Central Connect, our new customer portal available via their individual extranet website. This new tool, accessible to all accredited customers, can help with survey preparation for  and laboratories are asked to enter the following information into the portal:

  • Identify key laboratory personnel—lab director, technical supervisor, general supervisor, technical consultant, and clinical consultant. The roles required are determined by the complexity level of the testing being performed at a given laboratory. Of note, CLIA requires that these roles be assigned to someone within each laboratory. This can be something of a challenge for those laboratories that have staff performing the actions of these roles, but whose titles have not been identified by these exact CLIA terms. This identification is particularly important for competency testing, as CLIA regulations are very specific about who can perform competency testing. Links to the qualifications for each role are located within the Lab Central Connect site.
  • Is referral testing performed? Active referral testing will prompt surveyors to apply the appropriate state laws.
  • Include cytology workload and annual test volume statistics for all primary screeners for both gynecologic and non-gynecologic cases. These are required by CLIA and will be reviewed on every survey. 
  • List each test system in use, by analytes. This determines the specialties and complexities indicated on the CLIA certificate, as well as which documents need to be reviewed. The program uses the FDA CLIA database to provide a list of instruments and analytes by instrument.   

Once this information is entered, the surveyors will be able to access the information to review prior to the actual survey. This approach will allow for a smoother survey process, enabling the surveyors to focus on the on-site interactions, including customized education for each laboratory. Furthermore, there are additional opportunities to use Lab Central Connect’s document repository and other survey preparation tools for the laboratory. In the near future, the program will also have the capability to upload PT results from the testing providers, which will provide even more information for the surveyors and the laboratory to use in their ongoing compliance efforts. 

MLM: What are the key areas to identify and target when conducting an internal audit?
Rhamy: In general, performance improvement (PI) activities in the laboratory should be perpetual and there is a separate PI chapter in The Joint Commission’s standards manual that discusses how data should be used to improve performance and outcomes. While many labs collect PI data, a lesser number use it to guide their priorities and fewer still use the data as an integrated tool to work with clinical services and organizational leadership to drive integrated improvements. In The Joint Commission’s program, there are many shared PI standards across hospital and laboratory programs intended to drive a cooperative approach to improving the services and care provided to patients. 

The Joint Commission has a process called Intracycle Monitoring, which is part of the ongoing accreditation process for all accredited laboratories. Improved from the previous periodic performance review (PPR) process, the Intracycle Monitoring process is conducted approximately 12 months after a laboratory’s last survey and includes a conference call between representatives of the lab’s organization and a member of The Joint Commission’s Standards Interpretation Group (SIG). During the call, the SIG staff will discuss standards identified as high risk as well as answer the organization’s standards compliance questions. In order to encourage open communication, the notes from these calls are not shared with surveyors and have no impact on the next survey. One excellent way to prepare for this call is to perform an internal mock tracer to identify any vulnerable points or questionable areas in the laboratory’s system so those areas can be reviewed with SIG staff. There are documents located on The Joint Commission’s website that describe how to perform a mock tracer, likewise, additional resource literature is available from our sister company, Joint Commission Resources. 

MLM: What other resources are available to lab managers for further information on Joint Commission surveys and compliance?
Rhamy: The laboratory accreditation page on The Joint Commission’s website provides a treasure trove of educational materials. 
Visitors—both accredited and non-accredited—can find links to our newsletter and the archive of previous issues, slides from past audio conferences, links to other professional organizations, CMS forms, a list of industry documents available for laboratories by specialty, frequently asked standards questions, resource documents for Lab Central, our blog, and more. 

For accredited laboratories, members can access more detailed educational resources through their aforementioned extranet site and Lab Central Connect. The following are examples of resources available to current Joint Commission accredited labs:

  • A Leading Practice Library with procedures and forms shared by other laboratories that have been reviewed by staff for compliance with standards.  
  • A library of booster packs—reference booklets on complex standards—can be accessed. One booster pack addresses sample collection and is written for clinical areas and laboratories to understand the requirements and rationales.  
  • The Lab Central Connect portal has dynamic educational resources embedded, such as a video and PowerPoint slides on proper calibration verification. 
  • Laboratories can access an electronic copy of the standards with search features. The standards can be customized through the applicability grid to only show those standards for the specialties performed by your specific lab.
  • Perspectives, the official newsletter of The Joint Commission for accredited customers, is also available.

Jennifer Rhamy, MBA, MA, MT(ASCP)SBB, HP, currently serves as  the executive director for the laboratory accreditation program at The Joint Commission. Previously, she worked as a blood center consultant and served as vice president of laboratory services for the Indiana Blood Center in Indianapolis. In addition, Jennifer served on the board of directors of the AABB and is a past-president of the Indiana State Association of Blood Banks and the South Central Association of Blood Banks. She received her BS in medical technology from the University of Arizona, her MBA from Colorado State University, and is a registered medical technologist with a specialty in blood banking. Jennifer also is registered as a hemapheresis practitioner by ASCP and holds a certificate in Lean Six Sigma. 

For more information on laboratory accreditation by The Joint Commission, visit:
http://www.jointcommission.org/accreditation/laboratory.aspx

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