Inspection Techniques in Checklists
The CAP has begun to restructure its onsite inspection tool to provide specific direction to inspectors on conducting effective inspections, including better documentation of inspection findings. In October 2005, the CAP began including inspection techniques that can be used to gather information about the laboratory. Such techniques include communication with bench-level personnel and direct observation of testing to ensure written policies and procedures reflect actual laboratory practice.
Checklist for Assessing Lab Director Effectiveness and Responsibilities
In 2006, CAP inspection teams will place more emphasis on assessing the effectiveness of the Laboratory Director. This assessment focuses on director authority, involvement and oversight in implementing the laboratory's quality management plan, including CAP's new patient safety goals and, in general, maintaining CAP accreditation standards. A new checklist to guide this evaluation was approved for this purpose in October 2005.
Ongoing Monitoring for Sustained Compliance
The CAP will strengthen its ability to monitor a laboratory for sustained compliance throughout its two-year accreditation cycle. Laboratories that exhibit quality concerns may warrant further action, such as periodic requests between inspections for documentation (i.e., quality control charts, graphs, meeting minutes, etc.) and conducting unannounced, non-routine inspections. Additionally, to assist with ongoing monitoring, the CAP will be developing a sophisticated computer program that will integrate quality factors, such as proficiency testing results and trend analysis, inspection findings and complaints, into knowledge management for effective accreditation decision-making and for a more comprehensive, multi-dimensional assessment of laboratory performance.
Mandatory Inspector Training
The CAP will strengthen the qualification requirements for inspectors through the mandatory completion of CAP-prescribed training. Training will promote a consistent understanding of program standards and will ensure a uniform application of techniques to achieve a more consistent and effective inspection. Mandatory training will be required for all Team Leaders assigned after July 2006. Mandatory training is also planned for Team Members.
Unannounced Routine Inspections
In mid-2006, the CAP will begin to conduct routine, biennial inspections on an unannounced basis. This process will not only reassure the public about the objectivity and integrity of the inspection process, but will also give laboratories the opportunity to demonstrate ongoing compliance with CAP standards. As part of the unannounced inspection, the laboratory will not know the date of its accreditation inspection, nor will it be told in advance the name of its inspection team leader or team members. The window for unannounced inspections will be 6 months immediately prior to the lab's anniversary date. Labs will be afforded 10 blackout dates in which no inspection will occur.
Internal Validation Process
Beginning in 2006, CAP will conduct validation inspections of some accredited laboratories in order to assess the effectiveness of program changes (e.g., unannounced inspections, training, checklist revisions) and the performance of inspection teams. This internal validation process will augment the validation information from CMS, providing an important new source of data to measure the consistency in our inspection process.
In order to validate team assignments, the CAP has begun to centralize this process, thus ensuring that inspection teams are objectively selected and appropriately matched to the size and complexity of the laboratory being inspected.
The CAP is abiding by a draft communication protocol developed by CMS in consultation with accreditation stakeholders. The protocol establishes criteria for the exchange of information that will facilitate the identification and resolution of issues of non-compliance that may affect quality of patient testing. As part of ongoing monitoring, CAP will communicate the names of labs, exhibiting quality concerns, to CMS, state authorities and other appropriate accrediting organizations for their potential review.
In January 2006, the CAP will begin distributing a DVD to all laboratories, which explains the accreditation cycle and encourages the active participation of laboratory personnel and interaction with CAP inspectors.
CAP Hotline and Employee Protection Policies:
Initiated in October 2004, the CAP will continue to require the posting of a sign in each CAP-accredited lab, which provides a toll-free number for laboratory staff to call if quality issues are not adequately addressed within their institutions.