Fast Track to Accreditation: An Implementation Review of College of American Pathologists and International Organization for Standardization 15189 Accreditation

Accreditation is a procedure by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks.¹  As efforts to expand services continue, increased attention to quality, efficiency and cost effectiveness is paramount.²  The latest report of the Institute of Medicine, titled “Improving Diagnosis in Health Care,” ³  is entirely focused on diagnostic errors and means to improve diagnosis in health care. Three of the 8 goals provided by the committee creating the report have direct links to laboratory accreditation, namely, goal No. 2: enhance health care professional education and training in the diagnostic process; goal No. 4: develop and deploy approaches to identify, learn from, and reduce diagnostic errors and near misses in clinical practice; and goal No. 5: establish a work system and culture that supports the diagnostic process and improvements in diagnostic performance.³  Accreditation provides the perfect means to address these goals and verify that laboratories are adhering to quality and competence standards necessary for accurate and reliable patient testing.² 

International accreditation services for clinical laboratories can be obtained from the College of American Pathologists (CAP), Joint Commission International (JCI), United Kingdom Accreditation Services, National Association of Testing Authorities in Australia, among others.

The international standard ISO 15189 addresses the requirements for quality and competence in medical laboratories.¹  It has its origins in the competency requirements of International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025⁴  and the quality management system (QMS) requirements of ISO 9001.⁵  Fulfilling those requirements is objective evidence that the laboratory meets both the technical competence as well as the management system requirements that are necessary for it to consistently deliver technically valid results.¹  Competence is a broad term, defined as demonstrated ability to apply knowledge and skills.²  It incorporates qualification, training, and experience. This is mostly addressed in clause 5 of the ISO 15189:2012 standard. The management system requirements that are addressed in clause 4 of the standard provide the road map to a process-based QMS aimed at enhancing customer satisfaction by meeting customer requirements. This is achieved broadly through defining management responsibility, managing resources, product realization, measurement, analysis, and continual improvement of the QMS.⁵  ISO 15189 was first introduced in 2005 with rapidly growing international adoption.⁴  In the Emirate of Abu Dhabi, ISO 15189 has been made mandatory by Abu Dhabi's main health insurance company as well as Abu Dhabi Quality and Conformity Council for Medical Laboratories as of January 2017.

The CAP founded its accreditation program more than 55 years ago in 1961. It includes more than 7945 laboratories in the United States and more than 430 laboratories in 50 different countries.⁶  The CAP's Laboratory Accreditation Program accredits the entire spectrum of laboratory test disciplines with the most scientifically rigorous, customized, and objective checklist requirements. The CAP's peer-based inspector model provides a unique balance of regulatory and educational coaching supported by the most respected worldwide pathology organization.⁶  Circa 2010, only 2 CAP-accredited laboratories existed in the United Arab Emirates (UAE): one in Abu Dhabi and another in Dubai. Fast forward to the present day, there are now 45 CAP-accredited laboratories in the UAE, and the list is growing.⁶  The Laboratory Accreditation Program revolves around 4 standards: evaluation of the laboratory director, physical facility and safety, quality control and performance improvement, and finally, the inspection requirements.⁷  The assessment of the laboratory is based on a series of 18 checklists that are section-specific, in addition to an All Common Checklist, Team Leader Assessment of Director & Quality and Laboratory General Checklists. CAP offers its accreditation independently or combined with ISO 15189. In countries where an existing ISO accreditation body is a mutual recognition arrangement signatory to International Laboratory Accreditation Cooperation (ILAC), it is advisable to obtain ISO accreditation through that body. In the UAE, Emirates International Accreditation Centre (EIAC), formerly known as Dubai Accreditation Department, is the signatory to ILAC and offers accreditation services for clinical laboratories in the country.

Our journey started with Cleveland Clinic Abu Dhabi's (CCAD's) activation of clinical services in March 2015. Assembling a workforce of technical and medical laboratory professionals from more than 30 different countries was truly remarkable, although not unique to CCAD. Many hospitals and medical laboratories in this part of the world will relate to the fact that a globally diverse workforce will carry with it varying clinical practice backgrounds and cultural experiences. In this environment, the laboratory leadership team made a deliberate decision to use accreditation as a tool to establish and ensure quality and to standardize our practice and processes to the best international benchmarks.

We decided, as a team, to first pursue CAP accreditation, followed by ISO 15189. There were several reasons that led to this decision. These included the team's familiarity with CAP accreditation process and requirements; CAP's objective and detailed checklists with clear requirements for evidence of compliance; alignment of our laboratory with both the Cleveland Clinic main campus laboratory at Cleveland, Ohio, and also with our local partner, the National Reference Laboratory in Abu Dhabi; and finally, aligning our efforts with the hospital-wide goal of pursuing JCI accreditation that recognizes CAP accreditation.

The biggest challenge in preparing for accreditation resulted as a direct reflection of our startup status, compounded with competing priorities and accelerated operational timelines. Team dynamics and work culture were still evolving and comfort levels in the new environment growing. Manpower was a particular challenge, as we were not fully staffed; however, workload was equally low in the initial months, which afforded us the ability to focus on quality and accreditation as well as delivery of clinical services.

Document control was the second largest hurdle we had to overcome. We used a manual system initially, but after observing gaps in efficiency and in controlling records and forms, a request to automate the system electronically was made and successfully implemented in early 2016.

Method validation perhaps took the longest time to complete. Obtaining microbiology samples in a startup environment was difficult, since securing positive controls took time to locate and acquire. We relied heavily on the assistance of neighboring hospitals that are also CAP accredited. Having a standardized approach to all method evaluation protocols enabled us to finish just in time before patient testing services were initiated.

Measurement uncertainty is an ISO requirement that we had to establish and monitor. Various formulas exist to determine the value of uncertainty of measured quantity values.^8,9  We found the guide published by the Royal College of Pathologists of Australasia¹⁰  as well as the publication by the Australian National Pathology Accreditation Advisory Council¹¹  to be very helpful and practical and it fulfilled EIAC requirements.

Shortly after reviewing our safety program, our team quickly realized that it was not optimally coordinated or substantively managed. We needed to assign the role of the safety officer to 1 member of the team to ensure full accountability, training, and implementation. CAP training resources were of great benefit to us in this regard and it was the most efficient way to ensure compliance in a short and objective manner.

An area of poor compliance was our environmental conditions related to room temperature monitoring and records. It was not until we installed an automated and reportable temperature monitoring system that we got this aspect under satisfactory control.

A functional and user-friendly laboratory information system (LIS) platform is critical in establishing reliable and accessible patient information, productivity data, and quality metrics. The absence of LIS automation leads to a level of human error along with the proliferation of manual, nonvalue added steps. In building our LIS platform, a significant amount of work from a multidisciplinary team went into planning, testing, and adopting Cleveland Clinic main campus LIS. It was in this endeavor that a number of valuable lessons were gained.

Validating our LIS system according to CAP and ISO requirements demanded deliberate and persistent efforts and frequent communication among team members. This work allowed us the advantage of setting the quality bar high, right from the inception of the laboratory operations. Initially, some key elements required by ISO, such as the primary sample type and the measurement procedure, were missing, but this gap was quickly identified and resolved as per standards of report content and attributes established by ISO standard 5.8.3¹  and CAP General Checklist, GEN.41096.¹² 

Although the key performance indicators to be measured were clear from the onset, obtaining these data from our LIS and its validation was another challenge that took longer than anticipated. Luckily, through structured meetings and project management, we were well prepared before the CAP inspection.

The point-of-care program posed its own challenges, as our nursing colleagues were also equally occupied with activation activities throughout the hospital and spread thin with various competing priorities and limited resources. We worked closely with the nursing education team and created online training and competency assessment tools. We also used various middleware solutions to assist in the remote management and virtual oversight of the program.

Our first version of the quality manual was drafted as per the World Health Organization (WHO) recommendations and Clinical and Laboratory Standards Institute (CLSI) guidelines.¹³  While it sufficed for CAP inspection, we realized that it required to be structured according to the ISO 15189 requirements. It had to address all 15 elements of the management requirements (4.1–4.15) and additional 10 elements of the technical requirements (5.1–5.10) with cross-reference to all relevant policies, procedures, and processes in each section. Preparing the quality manual according to the ISO requirements assisted us in addressing any potential gaps for ISO 15189 and still complying with all CAP requirements.

Section 4.9 of the ISO 15189 stipulates that the laboratory shall have a documented procedure to identify and manage nonconformities in any aspect of the QMS.¹  Nonconforming activities can be identified in many different ways including clinician complaints, internal quality control indications, instrument calibrations, staff comments, and audit findings.¹  Although we have an automated occurrence reporting and management system in use at CCAD, it focuses on capturing patient safety–related events or occurrences. We realized that it was not capturing all potential nonconformities as per ISO requirements. We then had to introduce what we called a “Quality Improvement Form” or QIF to capture all other non–patient safety-related nonconformities and staff comments. This measure has proven to be a success as comprehensive lists of occurrences are actively captured, shared, and monitored among the team.

Internal audit activities are another ISO requirement where we observed gaps. Implementing a comprehensive internal audit program turned out to be the key element in the continuing improvement cycle and in our success in achieving accreditation. There are 2 main methods used to conduct audits: vertical and horizontal. Vertical audit examines more than 1 element in a process across 1 item.¹⁴  It is similar to the tracer methodology used by JCI and CAP in tracing a sample through the entire testing cycle from receipt to report. Horizontal audit examines 1 element in a process across more than 1 item, for example, equipment management or document control across the various sections of the laboratory.¹⁴  A third form of audit termed witness or examination audit can be incorporated into either methods and it is used to establish that a person is able to carry out the activities required by the procedure.¹⁴  We created an audit plan, an audit tool, and got members of our team trained as certified ISO 15189 internal auditors. This training of auditors is important. Auditors have to display 5 principles: they have to be ethical, professional, fair, independent, and evidence based.¹⁴  ISO 15189 stipulates that audits shall be conducted by personnel trained to assess performance of managerial and technical processes of the quality management system.¹  We certified our lead technologists (supervisors) and some of our technologists and pathologists to become ISO 15189 auditors by undertaking a 3-day course followed by an examination. We also used the WHO AFRO's Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist 9 to conduct our horizontal audits.¹⁵  The tool is based on the 12 quality system essentials of CLSI¹³  and gives a score from 0 stars to 5 stars that could be used objectively toward continuing improvement.

The role of the quality manager in the accreditation process is crucial. Coordination of the various activities, educating caregivers, validating key performance indicators' data, auditing, and controlling all documents were some of the key tasks our quality manager took on.

Cultivating a quality culture in any organization requires time. The advantage of fast tracking accreditation was its utility as a transformative tool from our inception. To foster a quality culture, we identified and assigned quality champions or advocates in each section of the laboratory. We conducted weekly quality forums where quality-related topics were discussed and deliberated. Additionally, we implemented a Just Culture, encouraging adverse event reporting with thorough follow-up and closure of those events. The laboratory leadership's involvement and commitment to quality helped a great deal in promoting this culture among all laboratory caregivers. We also offered structured continuing improvement training on Lean Six Sigma principles to all of our quality champions, technical leads, pathologists, and leadership to build a culture of problem solving and to nurture caregiver engagement and buy-in.

A structured management review under the ISO 15189 standard entails an annual review and analysis of 15 evaluation inputs to determine opportunities for improvement and changes required to the QMS.¹  The output from the management review is then incorporated into a plan with goals, objectives, and expected completion time frame. Since we were a startup operation, we started with performing management review monthly by using the 12 quality system essentials for close monitoring of operations and to streamline activities and rectify problems. As we matured into an established laboratory, we then adjusted our review to incorporate all 15 inputs and 3 outputs required by ISO.

Kim and Mauborgne¹⁶  published an excellent 4-step approach to the tipping point leadership. The idea in brief is to use a 4-step process to bring about rapid, dramatic, and lasting changes with limited resources.¹⁶  The cognitive and resource hurdles represent obstacles in formulating the strategy, while the motivational and political hurdles prevent rapid execution of the strategy. Tipping all 4 hurdles leads to rapid strategy reorientation and execution.¹⁶  We found this to be very true when we were implementing changes in a short time and with competing priorities. The following tactics were helpful to a successful implementation of this project.

For CAP we subscribed to accreditation and proficiency testing programs. We downloaded the checklists and studied them carefully. The checklists were pivotal throughout the entire process. They educated, guided, and provided an unequivocal method of assessing progress and compliance. We initiated a CAP Accreditation Steering Committee composed of Pathology and Laboratory Medicine Institute (PLMI) leadership, quality manager, section leads, and clinical heads. We then started educating all PLMI caregivers about CAP accreditation and standards by using CAP online training resources as well as didactic lectures, and formal and informal discussions.

The same approach was used when we were preparing for ISO 15189; we reached out to the EIAC. We had intense ISO training courses and certified a team of ISO auditors through official onsite training organized by EIAC. We then assessed our laboratory against the EIAC checklist for gap analysis, submitted the application to EIAC, and initiated a laboratory-wide ISO education.

Continuous improvement (CI) training and CI culture was not at a high standard or fully adopted when we started. We partnered with CCAD's Continuous Improvement Department and organized several workshops that we called “Brilliant Basics.” These workshops provided foundational knowledge and expertise to our technical leads and pathologists about CI and the various tools and methods that can be used. We selected real projects within the department to make training content more relevant and engaging for the team.

Conducting gap analysis helped us assess our current state against our desired goals, and we used tracking tools to monitor progress on closure of those gaps. The progress was discussed during the Accreditation Steering Committee meetings together with any challenges that were impeding progress.

We aggressively continued to recruit qualified staff as we embarked on this journey. CCAD top management was particularly supportive and swift in making required resources available. The organization and the team were both growing operationally and maturing in parallel. We divided tasks among different teams and agreed on timelines and key milestones to drive accountability and ownership. We also started training our own auditors, as mentioned before, using CAP Web site resources (QMEd courses)¹⁷  and on-site ISO training. A request was made to each section lead and clinical head to start preparing “compliance binders” that contained evidence of meeting the checklist requirements. SLIPTA and the EIAC assessment checklists were used to audit and track our preparedness for ISO accreditation.

Our internal auditors and technical leads served as ambassadors in disseminating the message and reinforcing the standards. Internal audits were extremely helpful, especially when conducted by different teams from various sections. In addition to internal audits, we also invited our peers from neighboring accredited laboratories to perform mock audits against CAP and ISO requirements. Peer review is a very powerful approach to creating team excitement around the auditing process and ultimately, accreditation.

Action plans were implemented from the audit reports and were used in the improvement journey. Empowering our caregivers to recommend improvements by using QIFs, as described previously, and to initiate changes was another important aspect to getting everyone involved and engaged in the process.

There were skeptics in the team and members who negatively affected the overall performance and morale of our caregivers. The timelines to obtaining accreditations were very aggressive (8 months for CAP from opening and 12 months for ISO after CAP accreditation), and the team was pulled in competing directions, mostly dealing with various growing pains that any new large-scale international health care organization faces. We felt early on that we needed to address the skeptics in the team through constructive dialogue and addressing obstacles and barriers. We had to put off the pressure until the time was right to push forward again. The Human Resources Department was a very important partner and we had to ensure continuous recruitment of high-caliber caregivers to fulfill our mission. Obtaining the license to open the hospital and the laboratory from the Health Authority of The Emirate of Abu Dhabi (HAAD) 3 months before the hospital opening allowed us to put many things in place to comply with HAAD requirements, which were excellent foundations to build on for CAP and ISO accreditation later on. Passing the HAAD licensing inspection was the first assurance to the team that we were on the right track to deliver excellent patient care.

We capitalized on our partnerships with both Cleveland Clinic main campus as well as the National Reference Laboratory in Abu Dhabi. Both institutions were essential to our success. Our fast track journey, key milestones, and activities are summarized in Figures 1 and 2.

In our experience, preparing for CAP directly impacted our readiness for ISO accreditation. CAP's real strength lies in the detailed technical requirements that are specific to each section. This level of detail does not exist in the ISO 15189 standards, which are mostly generic, uniform, and do not discriminate between the specific requirements of the various subspecialties within laboratory medicine. Subscribing to CAP Q-Tracks gave us both international benchmarks and goals for continual improvement. This worked remarkably well when we were addressing issues such as specimen rejection and turnaround times.

The biggest added advantage of ISO was the emphasis on the comprehensive QMS with attention to management reviews of inputs and outputs as well as customer requirements and satisfaction. The focus on audits and continual improvement activities were additional factors that gave us a step-by-step approach to operational rigor and continual improvement. Again the use of the SLIPTA checklist was a great help. We highly recommend laboratories pursuing ISO to make use of this tool, which is available free of charge for clinical and public health laboratories to use.¹⁵ 

ISO's risk management requirements are another area where a higher level of detail exists above that of CAP. In this regard, ISO requires a systematic risk assessment and proactive failure mode effect analysis for processes that may have a potential failure on examination results, which may affect patient safety. While this was incorporated in some of the Individualized Quality Control Plans that we developed for certain tests, we had to develop a systematic way to assess risks for the entire testing process.

Our accreditation experience, challenges, and opportunities were in many ways similar to those of others^18–21  who published their experience as well, although ours was perhaps the shortest. For the first author (L.A.O.) it was the first experience in a startup laboratory, but not the first experience with CAP accreditation.¹⁸  Guzel and Guner¹⁹  stressed the importance of a quality manual, proficiency testing, and the ISO 15189 application procedure itself. Henry Ford laboratories demonstrated the power of implementing lean culture and principles as their framework for ISO accreditation.²⁰  They also stressed the important role of a proper document control system as well as deviation management.²⁰  Okada et al²¹  discussed how ISO 15189 accreditation helped in reducing incidents, motivating staff, and improving competence in Okayama University Hospital, Okayama, Japan.

At the time of CAP inspection, we proudly dedicated our CAP accreditation to our patients at CCAD and to Raymond R. Tubbs, MD, former staff pathologist at the Cleveland Clinic and former chair of the CAP Immunohistochemistry Committee, who happened to be mentor of the lead inspector of the CAP team that inspected our laboratory in October 2016.

Accreditation provides the perfect means to building quality medical laboratories, and helps in improving diagnosis in health care and enhances patient safety. It is a goal that any new operation can reach, all the while establishing a strong foundation for quality improvement in operations. CAP and/or ISO standards are among the best to guide quality laboratory operations and are part of well-established accreditation systems that clinical laboratories could aim for. Both sets of standards have synergistic features to offer and, therefore, we recommend that laboratories seeking excellence in performance should consider implementing both. Laboratories seeking accreditation at an early phase of their inception will face challenges, but as we have chronicled, the reward of getting started on the right foot in establishing a culture of quality and continuous improvement will make the journey worthwhile.

We thank our colleagues in the Pathology and Laboratory Medicine Institute of Sheikh Khalifa Medical City (Abu Dhabi, UAE) for sharing positive patient samples for test validation/verification and for performing a mock CAP inspection to help us in our preparation for CAP inspection. We also extend our deep gratitude to colleagues at the National Reference Laboratory (NRL), who were our partners for the CAP and ISO 15189 accreditations of the joint CCAD/NRL Anatomic Pathology Laboratory at CCAD.