Laboratory Leadership’s View of Accreditation

May 2021 - Vol.10 No. 5 - Page #8
Category: Accreditation
 

Maintaining the necessary expertise to manage the laboratory accreditation process requires ongoing education. Despite laboratory directors’ familiarity with these biennial events, the prospect of the next inspection is often viewed with trepidation. Nevertheless, as with many such complicated issues, it helps to review one’s options with a fresh mindset. Herein we discuss, from a laboratory management viewpoint, the general approaches of both The Joint Commission (TJC) and The College of American Pathologists (CAP) to accreditation and contrast some of the options put before laboratory managers as pertains to regulatory conformance.

Program Structure and Detail

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) are the combined laboratory federal regulations dictating industry standards for clinical diagnostic labs. These amendments were made to the Code of Federal Regulations, specifically 42 CFR 493, and guide the three federal agencies responsible for laboratory compliance—the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC).1,2 When a laboratory seeks accreditation from TJC or CAP, they are purposefully seeking an organization that will perform biennial inspections (once every 2 years) on behalf of the federal government in compliance with CLIA. Both TJC and CAP standards meet the CLIA minimums and go beyond those minimums in many regards. The results of their inspections are sent to CLIA, which issues or reissues licensure, biennially. The inspecting body will also issue an accreditation, though this accreditation is not required for the laboratory to remain operational; only the CLIA licensure is required. While this article focuses on CAP and TJC, there are additional organizations that inspect laboratories on behalf of CMS and provide laboratory accreditation.

Laboratory CLIA licensure is based on the complexity of testing performed in that lab. Labs that do not perform moderate or highly complex testing are eligible for a waived CLIA license, which does not typically require inspection. However, those labs performing even one moderate or high complexity test require the corresponding license from CLIA, will be inspected a minimum of once every two years, and must meet the CLIA quality standards described in 42 CFR, subparts H, J, K, and M, as well as any additional requirements imposed by the representative body (eg, TJC, CAP, etc) selected by that laboratory or organization for inspection purposes. Further to this, it is important to understand that a CLIA license only covers one physical address. If a hospital operates two labs across the street from each other, both labs must have separate accreditation and each lab must meet every element of accreditation. Note that it is possible to have multiple CLIA licenses within one physical address.

CAP and The Joint Commission

The following subsections will cover various commonalities and differences between The Joint Commission and CAP pertaining to laboratory operations. Of note, this article does not address individual state requirements that range from the CLIA minimums to individual state licensure and inspection. That said, at least five states currently perform their own inspections—New York, California, New Jersey, Illinois, and Massachusetts. Further complicating the issue, state technician and technologist licensure is separate from state laboratory licensure, and whether tech or lab licensure (or both) are required depends on the state. Ultimately, lab directors should be aware of their state licensure requirements regardless of federal accreditation.

Inspection—CAP

As noted, laboratories have multiple options when it comes to agencies that can perform biennial inspections, but the two most common agencies are TJC and CAP. While they both operate using the base CLIA standards as a foundation, their emphasis and approach to compliance are dissimilar. CAP has historically been seen as the gold standard for laboratory accreditation, yet TJC has been gaining ground over the last few years.3 Even though hospital and clinical laboratories often share many commonalities, each lab is different, and therefore, each lab should consider the best option for its own operations. The following comparisons should be taken as part of a greater due diligence to determine the ideal approach for a specific laboratory.

Laboratory inspections performed by CAP are typically carried out by staff members from a different, CAP-accredited laboratory and are conducted over the course of a single day. The laboratory represented by the inspectors is typically similar in both size and scope to the facility being inspected, and the inspected lab will also gain the responsibility to inspect a facility in the future in reciprocity. An inspection team generally comprises a team leader (often a pathologist) and an additional number of team members dependent upon the size and scope of the laboratory to be inspected. Team member credentials may vary, as members can be a medical laboratory technician (MLT) or a medical technologist (MT) (now sometimes referred to as a medical laboratory scientist [MLS]), and do not have to be members of management. While CAP requires short training courses for inspectors, inspection teams can vary greatly in attitude, experience, goals, and approach.

The inspection method employed by CAP begins with a review of procedures followed by verification that the inspected lab follows those procedures. They will seek to determine whether the laboratory’s policies and procedures (P&Ps) meet both CLIA and CAP requirements. Likewise, they will seek to confirm that the inspected laboratory does, in fact, follow its established P&Ps. Note that where the laboratory’s practices meet those of the rest of the hospital receives less focus via the typical CAP inspection methodology. Although there can be a high degree of variation between inspections, this is the common approach.

Inspection—TJC

Inspections performed by TJC are conducted by a single MT/MLS who inspects dozens of laboratories every year and attends at least one annual conference to compare best practices with other inspectors. These practitioners generally have many years of laboratory experience and are evaluated annually on their inspection technique. Because a single individual is conducting the inspection, the inspections last longer (3 to 5 days) and tend to reflect greater consistency.

Inspectors from TJC often present a list of patients with specific conditions during specific time periods, then the laboratory must locate patients meeting those requirements in its records. For example, if an inspection was being conducted for the time period 1/1/19 through 12/31/20, an example might be, “Find a patient that had a critical CO2 between 4/1/19 and 7/1/19.” Once the list of patients is narrowed and identified, these patients will serve as the tracers, and everything about each patient’s stay will be examined. Continuing with this example, the maintenance and QC logs of the performing analyzer will be reviewed for the date on which the assay was run. The performing technologist’s employee file also will be reviewed. The floor or unit from which the critical call was made may be inspected to determine whether their critical policy was followed. The same may be done for every test performed on that patient during their stay. Essentially, every aspect of that patient’s care will be subject to review and there may be a deep emphasis on where the laboratory’s practices meet those of the rest of the hospital.

Presentation of Standards—CAP

In presenting its standards, CAP uses checklists for every department (eg, chemistry, microbiology, blood bank, etc), as well as a supplemental All Common checklist and two leadership checklists (Laboratory Leader and Laboratory General). Each standard on a checklist indicates the standard number, name, phase, a brief description, relevant notes, and the evidence of compliance. The phase can be graded as either 1 or 2 depending on patient impact, and this determination will in turn affect the method of response to any noted deficiency (phase 1 deficiencies do not typically endanger patients or staff, and require a lesser response than phase 2 findings).4,5 FIGURE 1 demonstrates an example standard for Hand-Off Communication from the CAP laboratory general checklist.6

Presentation of Standards—TJC

For its standards presentation, TJC uses domain checklists, such as Waived Testing, Environment of Care, Leadership, etc. Each standard contains a standard number, a brief description, the reasoning behind the standard, and the elements of performance (EP). Notably, any one standard may have multiple EPs and each individual EP may be cited as a deficiency. FIGURE 2 provides an example standard for Hand-Off Communication from a TJC checklist.

Presentation of Findings—CAP

Though an inspection with zero deficiencies noted is desired, laboratories are often presented with an opportunity for improvement in the form of a finding. How these findings are documented by the inspection team and addressed by the facility is disparate between the two organizations.

How (or whether) a CAP team notes a deficiency will vary between teams, but if a finding is noted, a single occurrence within the two-year inspected period may be viewed the same as a prolific problem occurring within the lab; this is an area on which the lab may want to seek clarification.

A list of citations by checklist will be generated by the inspection team. Unless you believe there has been some clear error in the process, it is not advisable to argue the findings with the inspection team, even though often, the inspected laboratory’s interpretation of these findings may be quite different from that of the inspectors. Regardless, the inspected laboratory is given a post-inspection opportunity to rebut all findings directly with CAP and this often results in the overturning of many of the findings. It may be beneficial to rebut all findings for which you have evidence with CAP for this reason.

Presentation of Findings—TJC

In recent years, TJC has moved to using its self-developed Survey Analysis for Evaluating Risk (SAFER) Matrix methodology to document findings. One axis of the matrix represents prevalence and the other represents severity to the patient. Using this method, a risk analysis is performed on each finding with different requirements to address the deficiency based on its placement within the matrix. All TJC inspectors are required to take a “see it, cite it” approach, so an inspected lab may have more individual findings than expected, but many of those findings will be in the low and/or limited categories and not require significant action to address. FIGURE 3 provides an example of this matrix.7

Additional Considerations

Although the inspection process is the most direct interaction, it should not be the only consideration in choosing an accreditation organization. Many laboratories have the option of engaging an accrediting body that differs from the rest of the hospital, for example. This can contribute to the siloed feeling that many labs encounter, as the number and timing of inspections may differ from the rest of the hospital. Some may choose the same organization that accredits the rest of the hospital to benefit from the convenience.

That said, laboratory leaders commonly voice concern over the perception that a laboratory not accredited by a more common professional association (such as CAP or TJC, among others) is somehow viewed negatively. The obvious continuation of this being that this perception could cost the laboratory clients, either in the form of outpatients, or outpatient physicians that utilize the laboratory’s operations. While these are important considerations, neither patients nor non-pathology physicians tend to be aware of CAP or TJC and bringing them into the equation should not be part of selecting an accreditation body.

Notably, one intriguing difference between CAP and TJC is that CAP will view multiple facilities as a system, under which there would only be one inspection over the two-year period for all hospitals. Facilities can share P&Ps and the entire inspection process can become less burdensome. However, an individual facility practice that is in need of improvement is more likely to be overlooked during a mass system inspection.

Conclusion

A final consideration of note is the reciprocal inspection process enabled through CAP. As mentioned, any laboratory inspected by CAP incurs an obligation to perform a reciprocal inspection on a laboratory of similar size and scope. Through this process, lab staff can be exposed to new ideas and new education to help improve best practices at their home facility. Sometimes relationships develop between the two laboratories and forms and templates are exchanged that benefit both operations. Spending just a day or two away from a home laboratory operation can provide a valuable team building experience for the inspectors.

Conversely, when TJC performs an inspection there is but a single resource to learn from and inquire about best practices. That said, that individual’s experience is typically much deeper than any other individual the inspected lab is likely to encounter based on how TJC chooses its inspectors. There is no right or wrong answer when it comes to choosing an accreditation organization, and a laboratory and any affiliated clinics or hospitals must find the best combination for their operations. In any case, be sure to take advantage of the resources and guidance provided by these organizations; do not fear their presence in your professional life.


Michael Veri, MLS(ASCP), MS, is currently serving the United States Military overseas as the laboratory advisor to more than 40 labs in over 20 countries. Michael and Christoff Coetzee are the principal authors of “Lab Management 101,” a free weekly webinar to educate current and future lab leaders.

 

References

  1. Willard, D. Definition: CLIA certified? CAP accredited? What does this mean? OralDNA. 2018. Accessed 4.20.21: oraldna.com/trends-in-salivary-testing/index.php/2018/03/09/definition-clia-certified-cap-accredited-what-does-this-mean/
  2. Smith, N. CLIA, COLA, & CAP: What’s the difference? Bioagilytix Insight. Regulatory Considerations. 2020. Accessed 4.20.21.
  3. Michel R. CAP loses accreditation clients to joint commission. The Dark Report. 2021;28(1). Accessed 4.20.21: darkintelligencegroup.com/the-dark-report/clinical-laboratory-trends/cap-loses-accreditation-clients-to-joint-commission/
  4. Boone WR. Overview of the College of American Pathologists (CAP) inspection process for assisted reproductive technology (ART) laboratories. J Reprod Stem Cell Biotechnol. 2011;2(1):41-45.
  5. Carlson DA. Laboratory Inspections: The View from CAP. Labmed. 2003;5(34): 373-380. Accessed 4.20.21: academic.oup.com/labmed/article/34/5/373/2657298
  6. College of American Pathologists. Laboratory General Checklist. CAP; 325 Waukegan Rd. Northfield, IL 60093. cap.org/laboratory-improvement/accreditation/accreditation-checklists
  7. The Joint Commission. Survey Analysis for Evaluating Risk (SAFER). Accessed 4.20.21: jointcommission.org/-/media/tjc/documents/accred-and-cert/safer-matrix/safer-infographic.pdf

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