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Eligibility
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To participate in System inspections, a highly-integrated group of affiliated laboratories must meet the System integration eligibility criteria. These are eight areas that are commonly standardized by fully-integrated Systems and Networks. Systems applying to participate in this inspection option must have all sites fully integrated for at least six of these eight criteria, and be working towards full integration in the remaining areas. For a fuller explanation of the criteria, refer to the second Eligibility question.
- One set of administrative policies for the system
- A single management team for the system
- A system-wide competency assessment program
- A system-wide quality improvement program
- A system-wide quality control program
- A common approach to managing patient data (eg, LIS/HIS/eMR)
- A system-wide safety program
- A system-wide process to manage sample collections and test requests
Labs which fulfill those criteria must also:
- Be under the same ownership
- Offer a comprehensive scope of services in anatomic pathology, cytology, and clinical disciplines across the group
- Be located within a three-hour drive from a centrally located laboratory (does not have to be the primary laboratory)
- Be able to provide a reciprocal inspection team every 18–24 months
- Be able and willing to travel outside their local area to conduct inspections
Example: A group composed of an affiliated hospital and several clinics with centralized anatomic pathology and microbiology services, which are all located within a three-hour drive of the centrally-located laboratory, and which meets six of the eight System integration criteria, would be eligible to be inspected as a System.
Part of being an integrated System includes significant standardization across all the System’s sites. We have identified eight areas that are commonly standardized by fully-integrated Systems and Networks. While it’s ideal for a System to be fully integrated on all these items, we also recognize that achieving full integration takes time. Systems applying to participate in this inspection option must have all sites fully integrated for at least six of these eight criteria, and be working towards full integration in the remaining areas.
System Integration Criteria:
- One set of administrative policies for the system: These policies may be considered “System” or “Corporate” policies, and address how the System complies with regulatory requirements. They typically address many of the Laboratory General and some All Common administrative issues, such as proficiency testing, quality programs, etc.
- A single management team for the system: There should be a centralized management team that provides oversight, direction, and accountability for all sites, fostering alignment with organizational goals and enabling coordinated decision-making across all laboratory leaders.
- A system-wide competency assessment program: A standardized program ensures that staff across the System are evaluated consistently and that the same policies and forms are used. Variations should be only to address differences in test methods/menus for a given site, or to address unique aspects of a discipline.
- A system-wide quality improvement program: A standardized program should encompass all sites and policies pertaining to all laboratories. There may be some metrics that are site-specific while others are applicable to all locations, but all should be discussed and reported through the system-wide reporting structure.
- A system-wide quality control program: Standardized quality control policies and processes ensure consistent test reliability and accuracy across all sites, reducing the risk of errors, supporting accreditation readiness, and ensuring comparability when patients move from site-to-site within the System.
- A common approach to managing patient data (eg, LIS/HIS/eMR): There should be a set of standardized policies addressing the handling and security of patient information and addressing the LIS requirements found in the Laboratory General checklist. For sites using the same LIS, report formats should be the same, critical values should be handled in the same way, corrected results should follow the same process, etc.
- A system-wide safety program: This should comprise at least a standardized program addressing safety policies, a process for assessing adherence to said policies, and processes for documenting safety concerns and corrective actions.
- A system-wide process to manage sample collections and test requests: This includes standardized policies and processes for specimen collection, labeling requirements, requisitions/electronic test request processes, etc.
We understand that new Systems may not yet be fully integrated in all the areas covered by the System Integration Criteria; however, we expect that a System will progress toward full integration over time.
At the time of application, all of the labs within a System must be fully integrated for six of the eight criteria, and should be working towards integration for the remaining items. For a fuller explanation of the criteria, refer to the second Eligibility question.
- One set of administrative policies for the system
- A system-wide competency assessment program
- A system-wide quality improvement program
- A system-wide quality control program
- A common approach to managing patient data (eg, LIS/HIS/eMR)
- A system-wide safety program
- A system-wide process to manage sample collections and test requests
As a reminder, all System laboratories must be within a three-hour drive from a centrally-located System laboratory (it does not have to be the primary laboratory).
Unfortunately, this restriction is necessary for logistics reasons. If laboratories in your System exceed this distance, we can work with you to distribute your labs across two Systems (or as many as needed) so that all your sites can participate in and benefit from a Systems inspection.
No, we do not require that Systems have the same instrumentation across all sites, though many of our System customers find there are significant benefits—both financial and operational—in doing so. Standardization does help streamline the onsite inspection process, and is often a goal for our Systems Inspection customers.
Our System laboratories find that the System Inspection Option has many benefits that help them save time and money:
- Moving all your laboratories to the same anniversary date gives you a single inspection window within your two-year accreditation cycle rather than dealing with multiple windows.
- Using the same checklist edition for all your sites for each inspection helps to level-set the standards you’re preparing against.
- Reducing the number of inspections that your team needs to perform—only one reciprocal inspection team every 18–24 months—means a noticeable reduction in the number and duration of staff absences for inspections.
Yes, all laboratories in a System will have the same anniversary date. This ensures that all labs are inspected using the same checklist edition.
When initiating the System Inspection Option, the anniversary dates for some laboratories may need to be moved ahead, resulting in more than one inspection in the two-year accreditation cycle.
The pre-inspection planning meeting is a valuable tool in helping with the inspection planning and logistics. The CAP Inspection Specialist, who is responsible for organizing and conducting the call/site visit with key system personnel, does so to gather details about the System in order to develop a proposed inspection schedule that will be shared with the inspection team. Whenever possible, the same CAP Inspection Specialist will join the team to provide inspector continuity.
Inspection Process
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A System inspection generally begins at the main site, where the team will discuss the plans for the inspection, then begin with a major document review on day one. On subsequent days, the team spreads out across the System to visit the other locations. Since the same policies, procedures, etc, are shared across the System of laboratories, they aren’t re-inspected at each location. When possible, the inspection team will use the same inspector for a checklist across all sites. For large Systems, it’s common for multiple sites to be inspected each day, and there may be more than one inspector covering each checklist. When this occurs, the inspectors are encouraged to keep in contact throughout the day to ensure consistency across their findings.
Each site has its own summation conference at the end of the inspection day. When the System inspection is completed, the inspection team delivers a global summation conference to discuss their findings across the System, highlight areas of integration where the System excels, and offer suggestions for further integration opportunities.
A global summation conference is in addition to the individual summation conferences done at each site. It’s presented at the conclusion of a System inspection, and provides an overview of the System’s best practices, areas where there are opportunities for further standardization, and/or areas where additional attention is needed to sustain compliance System-wide. The information presented at this conference can be used by the System administrators to prioritize and focus work efforts, especially for management and/or quality department staff.
Systems are asked to inspect comparably-sized Systems, and are typically asked to travel outside their local area to perform a reciprocal inspection. For example, the inspection of a seven-laboratory System typically requires approximately 10–12 inspectors over three to four days, plus travel time.
Yes, a CAP inspection specialist participates as a member of the inspection team. CAP inspection specialists are medical technologists with an average of 30 years of laboratory medicine and laboratory management experience. The CAP inspection specialist assists with:
- Managing inspection logistics
- Resolving any issues that arise onsite
- Assisting the team leader to ensure consistency in interpretations from site to site
- Preparing the global summation presentation
The CAP inspection specialist is also assigned a checklist to inspect.
Application Timing
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Laboratories should apply to the System Inspection Option at least one year in advance of the requested anniversary date. This will allow us to:
- Assign a similarly-sized inspection team for a true peer inspection: Currently, system inspections are assigned at least one year in advance.
- Move all System laboratories to the same anniversary date: Depending on the anniversary dates of all laboratories involved, some labs may need to move their inspection ahead, resulting in more than one inspection in the two-year accreditation cycle.
Fees
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Yes, participants in the System Inspection Option are charged a one-time application fee in addition to a yearly System fee—above and beyond each laboratory’s individual accreditation fees—based on the number of laboratories in the system. The System fee offsets the inclusion of a CAP Inspection Specialist and the increased travel expenses associated with the option.
The application fee is due with the submission of the System Inspection Application. The annual fee is invoiced at the beginning of each year and is sent to the primary lab in the group.
Email accred@cap.org to request an estimate for the System Inspection Option.