The Accreditation Journey for a Hospital in the Developing World Open Access

The journey to the first inspection took 2 years from the start of the scheduled laboratory accreditation plan, but the lapse of time from initial conversations to final preparations for a laboratory inspection was more than 3 years (Figure 1).

The hospital established a core team to initiate the project. The core accreditation team included the laboratory director, the heads of each subdiscipline (microbiology, biochemistry, hematology, and AP), a CAP LAP coordinator, 4 lead technicians, and 4 CAP LAP coordinators from each subdiscipline. This core group of 14 people oversaw each subteam, motivating them to focus on their aspect of accreditation, including enrolling participants and monitoring the PT Program. The CAP LAP leader functions as the laboratory director. He was accountable for all activities in the laboratory. A CAP LAP coordinator was tasked with connecting the laboratory with the hospital administration and governing boards. Four heads of subdisciplines were accountable for developing solutions to the checklists applicable to their specialties, with assistance from the lead technicians. Each subdiscipline had a nominated subdiscipline CAP coordinator in charge of managing and supervising the entire CAP project for their subdiscipline, in addition to communicating with the laboratory, hospital administrators, leaderboards, and CAP LAP representatives if required (Figure 2).

The CEO, chief medical officer (CMO) of the hospital, and head of the quality management department consistently participated, but it was necessary to identify at least 1 person to take the lead in resolving problems to ensure that barriers to progress were removed. For the first 1½ years, this core group met monthly to discuss the work accomplished. Later, the frequency grew to once every 2 weeks, then once a week, and finally once every 2 to 3 days during the last month before the first inspection.

We have gained extensive knowledge from CAP PT Program participation since the laboratory first enrolled in 2020. We made the decision to sign up for the CAP PT Program for all the tests on our activity menu, including all 4 subdisciplines, to compare our work with other laboratories around the world. The PT Program encompassed the entire spectrum of our activity, including the preanalytic, analytic, and postanalytic phases, as well as histology, cytology, and immunohistochemistry programs.

Before joining the CAP PT Program, the other 3 specialties had engaged in an external proficiency testing program in compliance with International Organization for Standardization (ISO) 15189:2012 standards for medical laboratories. In contrast, the AP specialty had not participated in any external proficiency program. Furthermore, none of the anatomic laboratories in Vietnam had been accredited under ISO 15189:2012 standards, nor had they participated in an external quality assurance program. So, participation in CAP PT marked the inaugural external quality assurance program for AP in Vietnam.

Use of CAP PT was required for accredited laboratories, which helps prevent internal disputes among our anatomic pathologists regarding cytopathology, histopathology, and immunohistology by providing us with external validation for our reference diagnosis or staining results. Furthermore, by participating in the CAP PT Program, we gradually learned how to categorize discrepancies into minor and major groups and what to do when a minor or major discrepancy is identified, allowing us to create the AP quality management system for our laboratory. This educational process became a new part of our laboratory culture, allowing us to view errors not as personal deficiencies but as learning opportunities to improve our system and processes. The outcomes of the PT Program were used to evaluate the performance of our pathologists and technicians, track the frequency of amended reports, and gain a deeper understand of our pathologists’ performance. It allows us to take actions to improve the limitations of our staff.

If the CAP PT diagnosis resulted in failure, our remedial activities would include conducting a literature review and promoting mutual education on that particular diagnosis, regardless of any discrepancies with the CAP’s interpretative results. An individual who rendered an inaccurate diagnosis would be selected to deliver the lecture and educate others. The lecture was required to take place within 2 months of obtaining the CAP PT evaluation. Because of active, ongoing learning, all pathologists studied together in the same language, making it simpler to advance and reach consensus.

Next, we started working on the checklists and our responses to checklist questions. When we examined our current procedures, we discovered that the other 3 disciplines—microbiology, biochemistry, and hematology—which were all ISO 15189:2012 accredited, would meet up to 60% of the requirements, but that our AP division had relatively few written policies that adhered to CAP LAP standards. However, owing to the JCI certification, the hospital already had general policies in place, such as hospital safety, infectious disease prevention safety, fire rescue safety, and requirements for human resources, among others. So as the AP division constructed our policy, we could refer to these policies.

Four checklists were required for AP, including the Anatomic Pathology Checklist (ANP), Cytopathology Checklist (CYP), All Common Checklist (COM), and General Checklist (GEN). Owing to the notable difference in the English capabilities of people in the AP division, it was preferable to translate these 4 checklists into Vietnamese so that other individuals who were not fluent in English could comprehend. Translation work was assigned to each of the pathologists and technicians. We spent a month translating 4 checklists. The translation stage was crucial to the success of this project because it required us to ensure that everyone understood every question on the CAP checklists. When ready to establish quality standards in the other Vinmec hospitals, we could easily interact with them because of the availability of these translated documents. English proficiency was still not very common among medical personnel in Vietnam.

Each of us began completing a checklist. Each member was given a distinct responsibility and deadline to write policy and procedure, requiring a complete comprehension of the checklists. Rather than classifying responsibilities according to the ANP, CYP, GEN, and COM checklists, we assigned duties based on specific tasks for each individual, contingent on the staff member’s abilities. These tasks included competency assessment programs, test method validation, instrument and equipment management, work environment and safety, immunohistochemistry, gross examination, and quality management program (Figure 3).

The most difficult section in the checklist is ANP.22978, which applies to the validation/verification of predictive marker testing. This requirement applies to both new and existing assays. As the first AP laboratory in Vietnam conducting assay validations and verifications, we encountered difficulties in obtaining tissue microarrays (TMAs) that were verified on validated assays. Consequently, we sought to get these validated TMAs from overseas sources for the validation of our assays. These validated TMAs were likewise expensive to purchase.

At the early stage, we were unsure what exactly standard operating procedures were. By researching through references, we continued to learn and comprehend what the standard operating procedures should be, how they should be formatted, what elements should be included, and how we could ensure laboratory personnel would be familiar with them. Following this stage, we held lectures and trained other pathologists and technicians. The new policy and procedures were then established by initiating a draft version, then going through a discussion phase until finalization.

At the second stage, all pathologists and technicians participated in regular morning meetings that lasted between 1 and 2 hours daily. The draft was reviewed to ensure that the checklists were addressed and policy implementation was practical. The meetings were held by the aforementioned key players, including the head of the AP division, 2 supervisors, the AP lead technician, and a technician with expertise, to find consensus. If there was disagreement, further literature searches were performed to ensure decision-making was objective and evidence based. We worked on these tasks for at least 6 months continuously and went through at least 3 rounds of debate to achieve agreement before moving on to the third phase, which involved educating all staff members on the newly implemented policy.

In the third phase, we attempted to integrate the new policy into our daily operations and document records. We conducted monthly reviews of the quality management program to ensure its effective implementation and make necessary modifications. This practice aided us in gradually implementing a new procedure within the existing framework without overwhelming our team.

In addition, we closely interacted with the entire laboratory in parallel with our AP division. Even though the other 3 subdisciplines were ISO accredited, there was still more work to be done. The core group members met once a month during the initial phase. We collaboratively finalized the GEN and COM checklists, verifying that all criteria met the fundamental requirements of the entire laboratory.

We effectively interacted with the CAP LAP staff in Northfield, Illinois, during the entire process via customer service email. For instance, CAP customer service connected us to the immunohistochemistry committee, which provided us with a thorough explanation of our questions. Communication with the CAP was primarily the responsibility of the CAP laboratory coordinator. In addition, each subdiscipline’s coordinator for CAP accreditation oversaw CAP accreditation on behalf of their specialty.

Moreover, we received tremendous support from the leadership boards of the hospital. In the second phase, we met with the hospital leadership team once a month, increasing to once every 2 weeks in the 3 months leading up to the first inspection. As inspection time drew near, the meetings with the hospital administration and the core team group became more frequent, occurring once to twice a week. We brought up what we were able to do at our monthly meeting with the hospital CMO and CEO. Fixation, for instance, was crucial for ensuring quality. To convince them of the crucial role of fixation and gain their support for getting additional doctors involved and compliant with the policy we had developed, we needed to speak with the operating department, the hospital CMO, the CEO, hospital administration, and other physicians.

In early October 2021, we conducted an initial simulated run in the laboratory. We assigned an inspector and applied the ROAD methodology—an approach that emphasizes Reading, Observing, Asking, and Detecting within each subdiscipline. Following this initial mock run, we held several meetings to further refine our process.

Two months before the inspection, we were able to prepare and conduct a second mock inspection successfully before the inspection time, thanks to the CMO and CEO and the quality management division. We carried it out in the same way as the actual inspection, visiting several faculties and asking staff members about their protocols. This action helped the leaders have a factual understanding of how their staff were performing, what they believed about the CAP LAP, how they adhered to the policy, and where they needed assistance from administration to improve, among other issues.

Following the second mock inspection, the CAP process assisted in discovering several deficiencies and provided recommendations for changes in our AP division. After closing the gaps and giving it some more thought, we realized that this was a fantastic opportunity to have the CAP assist us in seeing things that we were blind to on our own.

The COVID-19 pandemic forced a virtual inspection. After the preinspection meeting, each inspector moved to evaluate each subdiscipline. The inspection was required to be conducted in English and so we recruited 3 interpreters to assist with translation. The inspection process occurred as the staff continued their regular duties, enabling the inspector to assess the laboratory’s operations accurately.

The findings from the CAP inspection were reviewed in the summation conference and then communicated to the rest of the laboratory staff in Vietnamese. Although the deficiencies identified during the inspection were not trivial, they were all directed toward improving our processes, safeguarding patients, and ensuring no cracks in communication existed between the laboratory and clinical staff. Any laboratory being inspected for the first time—even with very rigorous preparation such as in our case—will have issues by virtue of the new eyes examining the laboratory. For us, corrective action sometimes required circling back to the inspectors to ensure we understood the intent of the citation and the standard.

We conduct the satisfaction survey on an annual basis. The results indicate that the incremental modifications implemented in our surgical report, in compliance with CAP cancer procedures, have enhanced doctors’ ability to identify and manage their patients more efficiently. Even though the turnaround time has not improved, and is even a bit slower as we implement the new approach, the quality of the result report has reached the international standard. Positive feedback from our clinicians has inspired us to keep going and uphold our commitment to continuously improve weaknesses.

The process of accreditation progressively transformed our laboratory culture. The quality standard guided our pathologists and technicians to collaborate toward achieving optimal test results for the patient. We are all aware that upholding standards is a continual endeavor and process that calls for our daily participation and attention. Reaching this point, however, has made it easier to visualize the path to maintaining quality in our routine work. We are aware that to stay current with the highest standards for the greatest patient care, we must constantly study, share, discuss, review, and revise what we have learned. Continuously learning from the CAP PT Program, attending virtual courses provided by CAP, attending the virtual conference, among other endeavors, and continuously learning and improving is part of our practice to keep up-to-date with the highest quality and what it means to be world-class. Health regulation is generally established by the Ministry of Health in our country. The government conducts annual inspections to assess general standards. However, the benefit of CAP accreditation is its specificity to our hospital laboratory, particularly in AP, as regulatory limitations and ISO standards have not yet been implemented in this field.

So why should developing countries like Vietnam be interested in completing procedures like CAP LAP? A significant reason is the recognition that, despite cultural differences in the perception of health care, there are universal principles that apply to all health care practices, regardless of location. This process of working together with hospital and system leadership and all the other laboratory sections to resolve differences, develop standard procedures and policies, and achieve consensus is a significant benefit to the laboratory. The positive feedback from our medical staff colleagues about improvements in our test quality and our patients’ experience because of our accreditation journey is another benefit that is difficult to value economically. Investment of enormous amounts of staff and leadership time, not to mention the costs associated with enrolment in CAP PT and the LAP Program, are significant. An estimated 20 000 hours have been delegated from all staff members plus more than $300 000 in proficiency testing during a 2-year period (Table). But the outcomes, even without attempting to account for unforeseen events, have been rewarding and of immense value, and they are likely to multiply with each succeeding year.

Our experience as a laboratory in a non–English-speaking country, however, also highlights the added economic burden that is imposed by the effort to follow an accreditation pathway established in an exclusively English-speaking organization. CAP LAP is a world-class standard, but if the goal is to become a truly international standard, consideration should be given to facilitating that pathway in some manner for non–English-speaking participants. Perhaps artificial intelligence or other technologic advancements can be deployed sooner rather than later to support other laboratories that lack the translation resources that were available to us. We did find that access to CAP members who were willing to answer questions and clarify uncertainties at early stages in our journey was of enormous help. Drawing on the international membership in CAP to foster this sort of international extension to the developing world would, in our opinion, be a wise move.

In achieving CAP accreditation, one of the most difficult and comprehensive quality management programs in the world, we have provided convincing evidence of the value of its high quality to the hospital and its patients. Being recognized for best-quality laboratory and outstanding service by the peer-review process used in LAP is very meaningful. We can now participate further in the peer-inspection process and impart lessons learned to other hospitals, not only in Vietnam but also throughout the world, by being determined and consistent with our commitment. Of course, to accomplish this, human labor alone is insufficient; financial support is also needed, but in the end, the value acquired is tangible and worthwhile.

The authors express appreciation for all those who made valuable contributions to this manuscript, especially Anh Thuy Le, BS, chief of operations of Vinmec Healthcare System (Hanoi, Vietnam), for her diligent review and editing; Rebecca Brum, BS, and Sami Ricketts, PhD, for their valuable contributions to formatting the manuscript; and Homi Yamada, a medical student at VinUniversity (Hanoi, Vietnam), for her thorough information retrieval.