Inspection Day is one of the most anticipated in the laboratory—and often it is one that causes the most anxiety. The laboratory staff may have come in early and stayed late for days leading up to the inspection, seeking to make sure everything is “just right.” When the inspector/surveyor or auditor arrives, he or she is usually welcomed profusely, but a palpable tension lies beneath the surface. That tension can, ironically, cause a lab to put less than its best face forward.
How can lab directors alleviate this anxiety and create and convey an atmosphere of calm professionalism? No, soft music and mood lighting are not the answer. Appropriate preparation is—along with “doing it right” all along. That is, if the lab has been running smoothly and in accordance with regulatory expectations anyway, there is less to prepare as Inspection Day nears. The inspection-ready laboratory (IRL) is one that is consistently ready.
Beyond that, however, there are several key questions to take into consideration to make inspection a less traumatic event—and to be an IRL.
Who is performing the inspection?
Inspections are performed by an outside agency that the laboratory has been approved by for accreditation. Labs are surveyed either by CMS/CLIA or by an accrediting organization (AO) which has been granted deeming authority by CMS. There are currently seven CMS-approved accreditation organizations: AABB, American Association for Laboratory Accreditation (A2LA), American Osteopathic Association (AOA), American Society of Histocompatibility and Immunogenetics (ASHI), COLA, College of American Pathologists (CAP), and Joint Commission on Accreditation of Healthcare Organizations (JCAHO).1 If a laboratory applies for accreditation by one of the CMS-approved accreditation organizations, the application process begins by first submitting an application to CMS for a Certificate of Accreditation (COA) concurrently.2 The CLIA program utilizes State agencies to conduct surveys, and the private organizations have trained surveyors as well that may work by region or nationwide.
Inspections are often announced in advance to the laboratory either via email, postal mail, telephone, or fax. Inspection schedules are subject to the time frames of the Accrediting Organization. CLIA follows a biennial schedule. Some private AOs follow an 18-to-24 month schedule, so it is prudent for laboratories to be additionally vigilant during these time frames. By documenting the date of the previous inspection, the laboratory will have a rough estimate of when the scheduled inspection may occur. The AO can always be contacted for an estimate of when the inspection may occur, if it cannot provide the exact date. It should be noted that if there has been a complaint against a laboratory, the inspection/survey may be unannounced.
What are the inspectors or surveyors looking for?
Inspectors or surveyors want to see whether the accreditation or certification criteria outlined in the laboratory’s accreditation or certification agreement are being fulfilled. The level of testing, test menu, and testing personnel are just a few components to be reviewed. If there are any noncompliance issues or deficiencies identified, they will be noted and a citation will be given. Citations may come with a penalty or require additional documentation or corrective actions, or may only be educational. Whichever the case, the laboratory must assess the citation and identify its root cause.
Jeanne Mumford, MT(ASCP), Laboratory Quality Assurance Specialist with Johns Hopkins Community Physicians, provides a summary of what the inspectors will do when they arrive at the laboratory:3
- Review policies and procedures
- Observe workflow and documentation
- Review all laboratory documents, EMR and LIS systems, and patient records
- Conduct an exit interview to outline any deficiencies, and give an overall grade.
What specific preparations can the laboratory make?
The inspection-ready lab has a comprehensive Quality Assurance (QA) plan that is not only reviewed annually for accuracy, but as needed for revisions and updates. The first place to start is with past inspection reports. Once the inspection is completed and the laboratory director has had the exit conference or interview with the inspector, all findings—good, bad or neutral—should be shared with the laboratory staff. By sharing the information in a timely fashion, the laboratory can begin correcting deficiencies immediately or praise and strengthen what has been working in the QA plan.
Any IRL should include in its QA plan not only internal assessments but external ones. It should have as part of the protocols a mini-inspection that can occur monthly, quarterly, or on an unannounced basis. Mumford also provides an excellent checklist for what laboratories should review as part of their internal assessment:
- General administrative & personnel
- Facility and safety
- Patient test management
- Proficiency testing
- Instrument maintenance
- Procedure manual
- Quality control. 3
She elaborates on this checklist by advising laboratories to establish a second, customized checklist that covers all tests performed and all documentation required for these tests, reviews existing checklists such as that of their AO, and allows for updates each year to accommodate growth and internal changes. These internal audits may suggest such categories to laboratories as “Training and Knowledge Deficits,” “Procedure Updates,” “Maintenance Pitfalls,” “Patient Safety,” “Staff Safety,” “Best Practices,” “Corrective Action Plan Successes/Failures.” By identifying and addressing these issues internally, the laboratory is better poised for the external audit to come.3
Laboratory directors can take the initiative to review maintenance records, QA documentation, and other records on a weekly and monthly basis to ensure that there is not a backlog when the annual review is to be completed. Technical personnel can be proactive and review information for accuracy prior to the laboratory director’s review. Another key to success is to address issues immediately and complete all necessary corrective actions with accompanying documentation.
The inspection-ready lab reviews its past inspection/survey reports, performs internal assessments, and constantly reviews the QA plan. Then it can welcome, rather than dread, Inspection Day. The lab that stays prepared maximizes its chances of success in the inspection process.
- List of approved accrediting organizations under the clinical laboratory improvement amendments (CLIA). http://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/AOList.pdf. Accessed August 4, 2014.
- Clinical Laboratory Improvement Amendments (CLIA).How to obtain a CLIA certificate brochure. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/HowObtainCLIACertificate.pdf. Accessed August 4, 2014.
- Mumford J. Internal lab inspections: how we stay “CLIA ready” at our physician office laboratories. CRI Annual Symposium for Clinical Laboratories. 2013.