Our ISO Journey - and the Consequences to our Operation
The speaker will present the journey to seek ISO-level accreditation by a high complexity laboratory. He will illustrate the choices made and the lessons learned– taking what may be seemingly escalating costs and challenges, and turning them into solutions with much organizational and corporate benefit.
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- Illustrate how the challenge of a much higher quality system might challenge an organization to adapt to the new system.
- Illustrate how some of the ISO level quality system actually precipitated considerable organizational efficiency and cost savings.
- Provide a probable roadmap and innovative for other organizations to deploy in their own institutions.
MR. STEVEN OLSEN:
Today I'm going to give you an overview of our ISO 15189 accreditation experience, in implementing ISO-level quality system. I'll tell you about our motivations for obtaining the accreditation and provide examples of some implementation challenges that we faced and our solutions to those challenges, as well as accreditation benefits that we have experienced so far.
MPLN is a small privately owned pathology and molecular lab with about 90 full-time employees. Our laboratory is located at the foothills of the Smokey Mountains in Merrillville Tennessee, with satellite location in Richmond, Virginia, which performs flow testing. As of early this year we have also established a footprint in the United Kingdom in Manchester.
MPLN was founded in 1989 and is a CLIA high complexity certified CAP and New York State-accredited anatomic pathology and molecular diagnostics laboratory. We perform testing in the areas of Women's Health, cytogenetics, molecular oncology, flow cytometry, anatomic pathology and genomics which is our next-generation sequencing division. We support clientele nationwide predominantly regional hospital and hospital systems, pathology practices, oncology practices, cytology and other reference laboratories. In 2007 MPLN formed Geneuity, a dedicated clinical trials division of MPLN that participates in clinical trial testing globally, and that division is our fastest growing division growing over 30 % in 2016. July of 2015 we became the sixth lab and only the second genetics lab in the US. To obtain ISO accreditation. Currently we are one of only 8 labs that hold that accreditation.
Why did we decide to become an ISO 15189 accredited laboratory through A2LA?
A2LA, by the way, is American Association for laboratory Accreditation. Well, first MPLN is a quality-driven organization, we are always looking for ways to improve our processes to pursue higher standards and ultimately provide to better patient care. As early as 2012 research organizations were inquiring more frequently about our intentions to pursue ISO accreditation and at that point it appears that accreditation is becoming an expectation for laboratories performing clinical trial testing in the United States and globally. Third, by obtaining the ISO 15189 accreditation MPLN would be able to position itself at a higher level than other competitive laboratories and additionally A2LA is independently accredited and internationally recognized by ILAC. CAP 15189 is only recognized in the U.S. and Canada. Independent accreditation ensures a hierarchy of accountability which promotes a higher level of quality and an internal … an international recognition allows data and results to be more readily accepted in overseas markets. And that was very important to us because we were already seeking overseas expansion.
Let's get into the timeline a little bit of how this came about. In May of 2014 we initiated the application process with A2LA, and received a copy of the ISO 15189 regulation. For the next 5 months we performed a rigorous internal gap analysis during which we compared our policies and procedures with the regulation. This analysis revealed a number of gaps resulting in new procedures, updates to our existing procedures, and Implementation of processes that were not required under cap or CLIA.
We submitted the application along with all required documentation in October of 2014, and the required documentation included any procedures which were cited as proof of compliance and other standard-required documents such as equipment lists, business associate agreements and staff breakdown.
Our A2LA assessment team was assigned and began to perform an offsite pre-assessment of our submitted documentation. In addition an onsite assessment was scheduled in advance for April to ensure that all key stakeholders would be present.
MPLN received the pre-assessment report from the assessment team in March of 2015. This report identified eight deficiencies observed in our submitted documentation, a majority of which were minor items requiring procedural updates and clarifications. For example the report identified that our contingency plan did not include provisions for a cease in laboratory operations. We just don't think about quitting work, and that the organizational structure was not located in the quality manual itself but in a different document. In both cases documentation was updated for compliance. It was also noted that our web-based document control system did not house the required A2LA documents. We included these required documents in our document control system to assure regular review and current updates, version updates. So in April 2015 our initial onsite inspection occurred. Two clinical assessors, an A2LA officer and our quality department, our laboratory director, department managers and other key stakeholders were present during a 3 day assessment. It is rumored that we broke our coffee consumption that week, I know I drank plenty myself. After initial facility tour, the A2LA assessment team conducted extensive document reviews, they examined our standard operating procedures, reviewed our quality management systems, verified all our certifications and licenses and reviewed quality control documentation and documentation practices throughout the laboratory. They also reviewed employee job descriptions, training and competency records and conducted management and staff interviews. Our information system’s infrastructure was thoroughly evaluated as well. On the final day of the assessment 20 deficiencies were cited, many of them were relatively minor and typical to those that we found during a CAP inspection, such as inconsistent reagent labeling or insufficient fiche image retention time, use of date format consistency, those kinds of things. Additionally A2LA required notification of proficiency testing results and changes, and as a response we gave A2LA access to our CAP proficiency testing and instituted a policy that all alternative testing, proficiency testing assessments would be uploaded directly to A2LA. Four recommended observations were cited, one of which suggested that we increase the staff in our quality division to address the increased oversight requirements. Shortly after the initial inspection, we added an additional quality person to the quality unit, with a specific concentration towards information technology and software development end. This person would also perform all other functions within the department such as quality control, document review, internal audits and non-conformance Investigations. Today I'd like to address six deficiencies that had the most significant overall impact to our quality management system and laboratory performance. They fall under the categories of equipment calibrations, software quality and development and risk management.
Three separate deficiencies were directly related to our equipment calibration process. First, our pipette calibrations did not meet the level required by ISO. At the time an external vendor was performing a level 3 calibration, which does not include the range information, of information required by ISO, namely the as-found state and a measurement uncertainty. In order to become compliant with the standard we changed our pipette calibrations to a level 6.
Secondly, employees who are performing in-house calibrations on all other equipment such as timers, centrifuges and scales were not being evaluated for competency. At the time each department was responsible for its own equipment calibrations. In response to this deficiency we had contracted with an additional external vendor to perform the remaining equipment calibrations to the ISO standard.
Thirdly, measurement uncertainty for calibrations were not being evaluated. Outsourcing all calibrations at the required level resolved these deficiencies. However, there was an appreciable cost incurred in doing so. Soon thereafter we began to evaluate other methods of keeping within compliance, but avoiding the significant costs of outsourcing.
The next two deficiencies that were cited on our initial assessment were related to software quality and development, A2LA identified evidence of incomplete documentation of our laboratory information system and the systems with which it interfaced. An investigation revealed that significant improvement was necessary in software development policies and procedures. At the time of the initial assessment we were working on a completely new