Though often dreaded, laboratory inspections are an essential process to ensure compliance with state and federal regulations and accreditation requirements. In fact, laboratory professionals and managers spend a significant amount of time ensuring that regulatory requirements are met to achieve accreditation.
The most valuable tool a laboratory has to help with complex accreditation requirements is its laboratory information system (LIS). Today’s laboratories require a strong LIS to function efficiently and breeze through the inspection process, as the LIS can track process steps and maintain required records such as operator certifications, quality control, and other documentation required for accreditation surveys.
Importance of documentation to accreditation organizations
Laboratory inspections are overseen by the Centers for Medicare & Medicaid Services’ (CMS) against the Clinical Laboratory Improvement Amendments (CLIA), which are regulations that establish quality standards for laboratory testing performed on specimens from humans. Even laboratories classified as waived must comply with applicable CLIA requirements. Laboratories are either inspected by CMS or an accreditation organization that has been given inspection authority by CMS. There are several CMS-approved accreditation organizations:
- Accreditation Commission for Health Care (ACHC)
- American Association for Laboratory Accreditation (A2LA)
- American Society of Histocompatibility and Immunogenetics (ASHI)
- Association for the Advancement of Blood & Biotherapies (AABB)
- COLA Inc.
- College of American Pathology (CAP)
- The Joint Commission
Preparing for an inspection is an ongoing process. If your laboratory is documenting properly day to day and leveraging its LIS tools, your lab should sit inspection-ready at all times with no need to rush around at the last minute collecting paperwork for an inspection.
Laboratories are required to provide all information and data necessary for CMS (or its accrediting representatives) to determine the laboratory’s compliance. All records and data must be accessible and retrievable within a reasonable amount of time during the inspection. A plethora of documentation must be available for an inspector, including:
- Personnel records (education, job descriptions)
- Proficiency testing records
- Training and ongoing competency evaluations
- Procedure manuals
- Reagent, quality control, calibrator storage, and tracking of reagent lot numbers
- Quality control records and Individualized Quality Control Plans (IQCPs)
- Quality assessment activities (corrective actions, annual QA review)
- Instrument calibration, maintenance, and function check records
- Temperature and humidity records
- Test requisitions and report forms
- Incident management plan and reports
- Instrument validation studies (precision, accuracy, linearity, correlations, normal range verification)
- Patient records/test results (critical values, audit trail)
Often, the most commonly cited deficiencies involve documentation of activities that can be tracked in some way within the LIS. For example, in 2021, the top cited deficiencies were as follows:
- Missing documentation of employee competencies (493.1235 - Personnel Competency Assessment)
- Incomplete monitoring of essential conditions for reagent and specimen storage, accurate and reliable test system operation, and test result reporting (493.1252 - Analytic Systems)
- Missing verification and documentation (twice annually) of the accuracy of any test or procedure it performs that is not included in subpart I or this part (493.1236 - General Lab Systems)1
Each of these requirements can be supported by your LIS. Many commercial LISs today offer personnel competency assessment tracking, documenting and reporting reagent and testing conditions, and documenting test accuracy verification studies.
How the LIS can help
All LISs are not created equal; however, many offer the ability to create and store records and reports for inspection. Below are examples of inspection requirements that your LIS should be able to track and document.
Data mining tools within the LIS can be tapped to mine patient data and create reports required for inspection (for example, test completion reports, turnaround times, utilization reports, and auto-approval reports). These reports can be set to auto-print at the desired time, pulling data for the specific dates desired.
LIS audit logs can track errors and user actions within the system, including any changes made and who made them. This is important to demonstrate that each step of the testing process is performed per defined procedures and to document which technologist performed each step.
The LIS contains advanced quality control features that track qualitative and quantitative quality control (QC) across testing locations. Quantitative QC can be monitored via Levey-Jennings graphs and Westgard Rules. Integrated logic within the LIS can be used to auto-order QC at the desired frequency and to deny result approval if QC results are not present or are outside of acceptable ranges. Intuitive filters can allow users and inspectors to review numerous QC graphs and accompanying comments without the need for paper printouts. Rules can be established to set up a weekly QC review to meet inspection criteria.
Reagent lot tracking
When lot numbers of QC and testing reagents change, this must be clearly documented so that you can track for each patient sample which lot numbers were in use when that test was run. For some specialties, parallel correlation studies between QC lots are required. An LIS can be used to track usage of reagent lot numbers and document parallel QC lot studies.
Quality assessment refers to different processes in each laboratory. However, the LIS has many tools that can help with whatever your lab selects for its ongoing QA tracking. For example, the LIS can track and document result discrepancies, incident reports, remedial actions, complaint investigations, analyzer comparisons, and pre-analytical, analytical, and post-analytical errors.
Some LISs can track personnel competencies and restrict operators who are not up to date on their certification. The LIS can track the due dates so that training and six-month/annual competency dates are not missed. It can be configured to send automated emails to operators when their certification is near expiration. Once certification is complete, the documentation can be scanned and linked to the operator. Some LISs can also link to a learning management system or allow the creation of quizzes, their auto-assignment to operators, and auto-recertification of operators based on lab-defined criteria. With these tools, your competency evaluation process becomes much more automated, which is especially important when you have a large number of end users for point-of-care testing.
Proficiency test reporting and tracking
Handling of proficiency testing (PT) is also reviewed in detail by inspectors. It is extremely important that PT samples are managed exactly the same as patient samples so that they actually “test” the process and operator competency. By using the LIS to track PT samples, you can set up PT just like you set up a patient so there is no question that the PT samples are handled as required. The entire testing process is clearly documented in the LIS. Over time, you can pull up historical PT results just like you would for a patient. And you can ensure that each lab employee takes their turn performing PT because the LIS automatically documents who does the testing.
Inspectors often will ask to “follow” a specimen through your laboratory’s processes to verify that each step along the way is properly performed and documented. If your LIS offers a workflow tracking tool or process engine, this tool can allow laboratories to track the status of their testing as it progresses through the analytical phase. Within the tracking tool, transitions between testing statuses can be triggered manually or automatically via various events. This allows the testing for each order to stay on the proper workflow process and ensures real-time status assignment with automated transition triggers.
Sample tracking in the LIS is helpful for inspection purposes as well. Sample tracking allows laboratories to track the movement of samples through the pre-analytical phase, as well as the storage and disposal of samples in the post-analytical phase. It may include a sample inquiry log that displays the history of the sample as it progresses through its life cycle. Sample tracking features bring overall transparency to the movement of samples through your laboratory’s various checkpoints.
Configurable decision-support rules are a powerful component of the LIS that allows users to automate processes and reduce errors associated with manual processes. Many areas within the lab can use rules to aid with inspection readiness and ensure consistent execution of procedures. For example, order entry rules can be used to manage test orders, such as splitting an order based on sample handling requirements.
Users can also create sequential test protocols or reflex testing that allows rule conditions to be based on results from previous tests. Additional rules that may be available can allow labs to automate label printing, update CPT codes, automate QC, auto-verify “normal” results, and schedule messages that improve communication and workflow.
Lab analyzer and EHR integration
Having interfaces between the LIS and your lab equipment and with your EHRs and reference labs provides a tremendous amount of automation and documentation of test orders and results delivery. In your LIS, inspectors can easily see incoming orders and outgoing results, verify that proper processes are being followed, and ensure that all required information is included on the test reports.
Test report setup
Per CLIA guidelines, the test report must contain the necessary information for positive patient identification, which includes the patient’s name and an identification number, the name and address of the laboratory where the test was performed, and a few other requirements specified in 493.1291(c): Post Analytic Systems.2 These requirements can be automated within your EHR–LIS interfaces.
Record & document retention
Before LISs were commonplace in laboratories, reams of paper were printed every month to comply with inspection requirements, and you had to save all these records for two years. Now, the LIS can basically save an unlimited amount of patient data and laboratory records so that paper is reduced and record retention requirements are easily met.
To make your lab inspection less stressful, make sure you are using your LIS to its full capabilities. Its role is to make your job easier and less error prone. Consider asking your LIS vendor for a checklist of the features and functionality that your LIS includes that can support your accreditation efforts.
In addition, there may be functionality that the LIS has that your lab team is unaware of, or your LIS vendor may release new features that can improve your inspection readiness, so be sure and take any opportunity available for additional LIS training and learn all that you can about leveraging your LIS’s tools to stay inspection ready.
- Division of Clinical Laboratory Improvement and Quality Centers for Medicare & Medicaid Services. Year 2021. Top 10 Deficiencies in the Nation – CMS Surveys. Accessed December 22, 2022. https://www.cms.gov/regulations-and guidance/legislation/clia/downloads/cliatopten.pdf.
- Code of Federal Regulations. § 493.1291 Standard: Test report. Accessed December 22, 2022. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFR9482366886d579f/section-493.1291.