Increasing trainee engagement and laboratory feedback during an internal laboratory inspection

Abstract

The inadequacy of laboratory management training has long been reported in the literature,^1-4 with various suggestions on ways to improve this aspect of pathology education and better prepare our trainees for the work of a staff pathologist.^5-8 The ACGME (Accreditation Council for Graduate Medical Education) milestones directly reflect this educational need and include a requirement of participation in an internal or external laboratory inspection to reach level four, the goal level for graduation, in the residency milestone Systems-based practice 5: Accreditation, compliance, and quality (AP/CP). There are similar requirements for many of the pathology fellowships, including Systems-based practice 4: Accreditation, compliance, and quality for blood banking/transfusion medicine, chemical pathology, cytopathology, dermatopathology, forensic pathology, hematopathology, medical microbiology, neuropathology, and pediatric pathology and Systems-based practice 5: Accreditation, compliance, and quality in molecular genetic pathology⁹ (for a description of milestones by level, seeTable 1). Furthermore, such participation has long been part of laboratory management curricula.⁸

TABLE 1. Summary of Accreditation Council for Graduate Medical Education accreditation, compliance, and quality milestones by level, with level 4 set as graduation level.

Level 1	• Demonstrates knowledge that all laboratories must be accredited
	• Discusses the need for quality control and proficiency testing
Level 2	• Demonstrates knowledge of the components of laboratory accreditation and regulatory compliance through either training or experience
	• Interprets quality data and charts and trends, including proficiency testing results, with assistance
Level 3	• Identifies the differences between accreditation and regulatory compliance; discusses the process for achieving accreditation and maintaining regulatory compliance
	• Demonstrates knowledge of the components of a laboratory quality management plan
	• Discusses implications of proficiency testing failures
Level 4	• Participates in an internal or external laboratory inspection
	• Reviews the quality management plan to identify areas for improvement
	• Performs analysis and review of proficiency testing failures and recommends a course of action, with oversight
Level 5	• Serves as a resource for accreditation at the regional or national level
	• Creates and follows a comprehensive quality management plan
	• Formulates a response for proficiency testing failures

The literature provides a few specific examples of departmental efforts toward using an internal inspection to support trainee advancement to level four of the accreditation, compliance, and quality milestone. In one report from the University of Florida, the trainees made up the entire inspection team, with the associate program director serving as the team leader. Four lunchtime seminars covering a range of laboratory management topics were provided, and preinspection and postinspection assessments were performed, showing a significant improvement in trainees' knowledge after the inspection.¹⁰ Another report from the University of California Irvine Medical Center describes a resident-led self-inspection of the department's histology laboratory and the subsequent decrease in deficiencies and improvement in staff satisfaction survey results for that laboratory.¹¹ Finally, a group out of Emory University created a clinical laboratory management curriculum that included preparation for and performance of an out-of-cycle mock inspection in one of the areas of the laboratory.¹² Those authors report that the curriculum was well received and provided objective measurements of mastery for a range of laboratory medicine concepts. Some subspecialties within pathology have created subspecialty-specific laboratory management education options as well.¹³

At our institution, we have long included residents and fellows in external inspections when possible and based on specific laboratory management interests and in our internal laboratory inspection in at least a cursory fashion; however, this past year, we made a special effort to increase trainees' comfort level and engagement with the inspection process. Our aims were to teach the trainees to see themselves as citizens and future leaders of the laboratory, to provide a lasting educational experience, and to deliver valuable feedback to our laboratory staff.

Our internal inspection process this past year

We have 19 residents and three fellows at our institution, and our internal inspection spans eight distinct laboratory locations. To introduce the internal inspection process, over a month before the inspection would begin, all trainees were required to attend a 1-hour Zoom meeting, held during our protected didactic time at noon. Trainees on vacation during the meeting were required to watch a recording of the meeting and were offered a separate time to ask questions. During the meeting, our quality program manager explained the process of an inspection, including the reasoning behind an inspection, a review of the documents that would be sent to inspectors, an estimate of the time required to inspect different checklists, a description of the ROAD (read, observe, ask, discover) process, and a comparison between a deficiency and a recommendation. The associate program director reminded the trainees of the ACGME milestone requirements the internal inspection would fulfill, emphasized the education they could glean from the process, and thanked them for their service to the laboratory. Finally, all trainees were instructed that they were obligated to complete the CAP (College of American Pathologists) inspection team member training and were strongly encouraged to set up a meeting, before their inspection date, to talk with someone who had previously inspected their assigned checklist(s). Documentation of CAP inspection team member training will be kept in the trainees' files going forward.

An email quickly followed the Zoom meeting with checklist assignments, instructions on how to access the CAP inspection team member training and how to access InspectionProof, where our institution's policies are linked and evidence of compliance with each checklist item is recorded. Finally, the trainees were given a list of faculty and staff who had previously inspected their assigned checklist(s). Checklist assignments were made by the associate program director, with an emphasis on trainees' future career aspirations. If possible, postgraduate year 1 residents were paired with more senior trainees. Our fellows were all assigned checklists based on the area of their fellowship. In total, 22 trainees inspected 14 distinct checklists in four locations, with most trainees using at least all common checklists and one additional checklist. Checklists and locations not inspected by our trainees were inspected by other laboratory staff. The inspection period was 2 weeks, straddling two resident rotations, allowing trainees flexibility in scheduling the actual inspection. All rotation directors were alerted to the upcoming inspection and instructed to be flexible with trainees rotation responsibilities during the inspection itself.

New this year, we strongly encouraged trainees to meet, before the inspection date, with staff or faculty who had previously inspected their assigned checklist(s). We hoped this would allow trainees to learn pearls and pitfalls of the inspection process for specific checklists and increase their engagement and comfort with the inspection process overall. Although we do not know exactly how many meetings took place between trainees and staff before the inspections, we know of at least 17 experienced inspectors who agreed to meetings and at least 11 trainees who asked for meetings.

One author (A.G.) personally met with trainees inspecting the anatomic pathology, cytopathology, and all common checklists. She encouraged these trainees to split the inspection process into three distinct sections: preinspection, inspection, and postinspection. For section one, preinspection, they were instructed to read through the documents provided with an emphasis on any new instrumentation or testing since the last inspection (noting that they would want to see any associated validations if applicable), previous proficiency testing failures, previous deficiencies, and any new or revised checklist items. She advised them to create a list, as they read in preparation for the inspection, of specifics they would need to lay eyes on, including policies, slides, records, and reports. She directed them to give this list to the laboratory supervisor as they began the second part of the inspection process, the inspection itself. During the inspection, or section two, she suggested the trainees follow the specimen while asking open-ended questions of staff members as they went. She also encouraged the trainees, as they followed the specimen, to ask staff for their thoughts on the most challenging checklist items and then how they manage those items to reveal challenges particular to each laboratory. For the anatomic pathology checklist, she directed the trainees to watch the embedding process, the process of slide creation, and a frozen section being performed from start to finish at a minimum. For the cytopathology checklist, she directed the trainees to watch a fine-needle aspiration with rapid onsite evaluation and the slide creation process at a minimum. While on site inspecting, she suggested the trainees take notes of any additional policies or documentation they might want to review based on what they were seeing and hearing. At the end of section two, she instructed the trainees to review all the items they had asked to see. Finally, during section three, or postinspection, trainees were encouraged to review their findings, discuss them with the supervisor(s) using nonjudgmental language, fill out the appropriate deficiency forms, and then thank the staff for their time and hospitality.

Reflection on our process

Surveys of the trainees and supervisors after the inspection were overwhelmingly positive. Through the inspection process, 100% of trainees reported they gained skills or knowledge that might help them in their futures as laboratorians, offering specifics ranging from a better understanding of what is necessary for a successful laboratory to function to new and improved ways to organize information. All supervisors reported that the inspectors were polite and respectful, and 94% reported being asked questions by the inspectors. Neither inspectors nor supervisors reported that it was very difficult to find a mutually acceptable time for the inspection, with 94% of supervisors and 83% of inspectors reporting that it was somewhat easy or very easy. Finally, although it is a small sample size and not necessarily causal, the number of deficiencies found by our trainees increased this year to 16 from two during our previous internal inspection, in which trainees were involved in the process but no special efforts were made to increase their engagement or comfort (Table 2). For all deficiencies found, corrective action plans are developed and implemented, leading to process improvement in the laboratory. Evidence of compliance with the implemented corrective action plans are saved for review during the next on-site inspection. We plan to follow the same process for assigning checklists in the future, emphasizing trainees' future career aspirations. Overall, we are pleased with the current iteration of our internal inspection process and hope to improve upon it in the future.

TABLE 2. Inspection deficiencies identified by laboratory section and checklist.

Laboratory section	Checklist	2022 self-inspection	2023 on-site inspection	2024 self-inspection
General	General (GEN)	1	1	0
Anatomic pathology	Common (COM)	0	3	0
	Anatomic pathology (ANP)	0	1	8
Chemistry	Common (COM)	0	3	0
	Chemistry (CHM)	0	2	1
Cytology	Common (COM)	0	0	1
Flow cytometry	Common (COM)	0	4	2
	Flow cytometry (FLO)	0	1	0
Microbiology	Common (COM)	0	0	2
	Microbiology (MIC)	1	0	2
Total		2	15	16