Sue Zaleski, MA, HT(ASCP), SCT
How one lab said goodbye to the frenzy and came up with a fresh approach
The CAP and the Joint Commission have incorporated unannounced inspections into their accreditation practices. Articles give details about how labs are coping with increases in regulatory and accreditation requirements, including the challenges of the unannounced inspection. Unannounced inspections do create concern and consternation for laboratory professionals. However, our first unannounced CAP inspection was deemed a resounding success and, in fact, it is preferred over the scheduled inspection.
This is the story of how our laboratory prepared for the inspection up to and including the knock at the door. The Emory D. Warner Clinical Laboratories are CAP-accredited and provide testing for a Joint Commission-accredited hospital, The University of Iowa Hospitals and Clinics, or UIHC. The unannounced inspection resulted in a paradigm shift from last-minute urgency to planning, preparation, and execution. Inspection readiness is an all-out laboratory effort, and we use a four-step quality control process—plan, do, check, and act (PDCA)—to keep us inspection-ready. The frenzy of the pre-CAP inspection activities is gone and has been replaced with a systematic approach that keeps us on course for inspection at any time.
The laboratory developed a quality-management plan based on the quality system essentials, or QSEs (Table 1). The QSEs provide the framework around which to organize policies, processes, and procedures and are applied to the preanalytical, analytical, and postanalytical phases of laboratory testing. CAP Maps were developed to ensure that policies or procedures, or both, are linked to CAP checklist items. An example of the CAP Map for cytology is shown in Table 2 (page 56). CAP Maps, policies, and procedures are available to staff online. Employees practice navigating CAP Maps to find information and answer questions. Being able to use the CAP Maps and to demonstrate that ability is an element of employee competency assessment.
In January 2006 the Joint Commission and the CAP adopted the use of tracer methodology. The “tracer” is an internal audit tool. The Joint Commission’s Continuum of Care uses tracing to evaluate how patient care processes deliver health care rather than looking at written policies and procedures. Presented in a corresponding manner, the CAP tracer method, called “follow the specimen or pathway,” assesses the appropriateness and timeliness of laboratory sample/specimen handling by “tracing” the sample through the preanalytical, analytical, and postanalytical phases of the testing process.
The UIHC Department of Pathology’s service team for quality, accreditation, and compliance develops an annual audit schedule. Members of this team conduct audits throughout the year to check each laboratory for readiness and to identify deficiencies, to which the laboratory responds with a plan of corrective action. The written plan must include an “implementation of corrective action plan,” which the director of clinical laboratories must approve. Subsequently, the corrective action(s) must be completed within 30 days. Issues for corrective action are often audited again at a later time to ensure the laboratory took corrective action and sustained the correction.
Staff members are questioned during audit, tracer, and inspection activities. Our goal is to prepare them for these interactions so they feel comfortable and confident. Staff members are trained to anticipate questions about the quality-management plan, safety, policies, procedures, quality control, and how quality control outliers are handled. Question-and-answer sessions are conducted continually through e-mail, at staff meetings, and during shift changes. Flash cards were prepared for and are used in each lab area. They contain last-minute “check” activities; managers distribute them to staff members when the inspection team arrives (Fig. 1). Through tracer audits, we identify problems that become the target for rehearsal sessions, and we take steps to make sure that correcting the identified problems becomes part of staff members’ daily work. Thus, staff members are intimately involved in laboratory preparation and training for inspector interactions.
Management team members and select staff were sent to the CAP inspector training. This training is an effective way to demystify the inspection process and strengthen working knowledge of the checklists. When possible, these individuals also participate on CAP self-inspection teams for other labs within the UIHC Department of Pathology. By becoming an inspector of a laboratory service that is outside of their areas of expertise, these staff members offered the benefit of trained eyes and ears for internal processes and procedures. Managers also observed increased self-confidence and competence among these staff members in their working knowledge of CAP inspection activities.
A fire drill is the universally accepted method of practicing the evacuation of a building for a fire, and the time it takes to evacuate is measured to ensure it is completed within a reasonable time. Fire drills are conducted periodically to ensure the evacuation is fast and efficient. We used this same method to practice receiving the CAP inspection team.
The UIHC has several entrances with information desks. Each information desk was supplied with directions on what to do and whom to contact when an inspector arrives. A drill was devised and put into play, with a member of the UIHC Compliance Department acting as an inspector. The length of time the inspector waited for a pathology representative was also tracked. The goal was to have the inspection team escorted to the pathology conference room within 20 minutes from the time it arrived at the information desk.
UIHC is a large and sprawling series of pavilions and towers that include a ¬680-bed hospital and a complex of multispecialty clinics. Laboratory services are located throughout the institution. Because of the size of the department, text pagers were used to notify the principal individuals—pathology administration, laboratory directors, laboratory managers, departmental and laboratory quality team members—of the arrival of the inspection team. Collaboration with UIHC telecommunications resulted in a workable plan for a text page message that prompts the principal to go to the pathology conference room to meet the inspection team.
We conducted several unscheduled drills to rehearse the arrival of the inspection team. Each drill turned up problems that were addressed quickly. We identified individuals to serve as backup members to the principals and developed a notification system for the backup members consisting of text page messages and phone calls. Staff members were alerted that an inspection team was on site by an overhead page broadcasting a welcome to the inspection team. A broadcast e-mail was also sent to the entire department. All of this information was compiled in a “rapid response” notebook. This red notebook contains the names of the principals, their backups, all contact phone and pager numbers, and e-mail distribution lists. It also contains the location of records and the time period for record retention.
The numerous drills conducted to prepare for the inspection paid dividends. The inspection team received a well-choreographed welcome. Each inspection team member received a new lab coat and a packet of information containing the items outlined in Table 3. After introductions, each inspector departed for the labs with an assigned escort.
While the inspection team made its way to the pathology conference room for introductions and escorts, members of the management team reviewed the work schedule to evaluate staffing levels and determine the availability of staff and managers. Staff members and managers used this time to print current CAP Maps, if necessary. Predetermined work areas, rooms, or both were cleared and cleaned for use by the inspector.
Historically, laboratory inspections consisted of interactions between the inspection team and the pathologists and supervisors. Unannounced inspections required a change from this outdated practice to a more active practice that engages employees in continual inspection preparation and involves them in the inspection itself. Our recent unannounced inspection was a favorable experience. We were impressed with the caliber of the inspection and the level of interaction between the inspectors and our staff members. The inspectors, using the “follow the sample” method, generated good questions for the staff. Staff reported feeling proud of their contributions to the inspection process and exhilarated by and confident in their own individual responses to inspector questions. The drill-down technique was also successful in identifying opportunities for improvements. In turn, the inspection team complimented us on our inspection preparedness and organization, and reported learning many valuable things from our preparatory activities and operations.
In conclusion, models such as PDCA, deploying a quality-management system throughout the laboratories, and using effective tools such as the CAP Maps and audits helped us to become inspection-ready and to maintain that readiness. These efforts keep us on the path to setting the highest laboratory standards and improving the quality of care for every patient every day.
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Facts about the Tracer Methodology. Joint Commission Web site. www.jointcommission.org/AccreditationPrograms/Hospitals/AccreditationProcess/Tracer_Methodology.htm. Accessed Dec. 12, 2007.
Sue Zaleski, a consultant to the CAP Cyto¬pathology Committee, is laboratory mana¬ger in the Department of Pathology, Uni¬ver¬sity of Iowa Health Care, Iowa City.