National Reference Laboratory Quality Dashboard Quality Improvement Metrics Q4 2016 INTRODUCTION Accreditation is an important tool used to demonstrate the commitment and competence of medical laboratories to ensure delivery of the highest quality results for clients and patients. The staff, at all levels of NRL, has adopted the principles of Continuous Quality Improvement, and accreditation is viewed as one goal that meets the minimum quality requirements by which NRL operates. Accreditation is the platform from which NRL continues to fine tune its programs and by which it has designed all initiatives for 2017 to achieve further quality enhancements and efficiencies and to share best practices within its network. In 2016, NRL successfully passed a record-breaking, nine, first-time inspections and an additional three re-accreditation inspections within its network. Below is a summary of the sites and their associated status for CAP, ISO 15189 and JCI accreditation. As a result of these efforts, NRL is currently the largest referral laboratory network in the Middle East to be accredited by CAP, with six accredited laboratories. To demonstrate the quality and reliability of our services, we are committed to maintain accreditation as one of our pillars of excellence; therefore, we will continue to seek accreditation through ISO 15189, and CAP (and JCI where required) for every additional laboratory we integrate into our network. NRL will continue to fine tune, in 2017, the Continuous Survey Readiness (CSR) program and expand the monthly audits with a quality management system review initiative. This endeavor provides an opportunity for implementing best practices, initiating continuous quality process improvements, and stimulating innovation. Laboratory CAP ISO 15189 JCIA NRL Industrial City of Abu Dhabi (Headquarters) Not applicable NRL Dubai (Q4 2015) (Q4 2015) Not applicable Imperial College London Diabetes Center (Abu Dhabi) Imperial College London Diabetes Center (Al Ain) Page 1 of 8
Healthpoint Hospital (Q3 2015) NRL Joint Anatomic Pathology Laboratory at Cleveland Clinic Abu Dhabi STRATEGIC QUALITY METRICS 1. Sharing Best Practices Sharing best practices is a key component of the pre-analytical process which ensures the successful integration of patient specimens into the laboratory. These activities provide a path to communicate knowledge of clinical laboratory process and operational outcomes to clients. There are many modes of sharing ideas, one of which is the formal presentation. A presentation provides an open forum for discussion and questions regarding current and strategic developments in laboratory testing. The more knowledgeable clients are about the processes and their importance within a clinical laboratory, the more enhanced will be the level of care they provide their patients. Action/Outcome: In Q4 2016, NRL concluded the year with a seminar entitled Quality Assurance in Clinical Laboratory Trends, Updates and Innovation held in both Abu Dhabi and Dubai. This was a very successful event in which over 100 people attended. We were pleased to receive positive feedback with the specific information that NRL is unique among the laboratories in the market because we offer CME seminars that are well-attended and organized with quality topics that are presented by knowledgeable speakers. In addition to the aforementioned seminars, NRL s Scientific Team participated in the following events in 2016: Event Speaker Topic Date MedLab 2016, Dubai Dr. Shereen Atef The Laboratory Cost of Poor Quality 25-Jan-16 MedLab 2016, Dubai Dr. Basel Altrabulsi Challenges in Next Generation Sequencing; Sample Preparation 26-Jan-16 to Data Analysis MedLab 2016, Dubai Dr. Frank Ryan Human Chorionic Gonadotropin Results - Not Always What You Think They Are 28-Jan-16 2 nd Laboratory Conference on Laboratory Test Method Quality Outcomes, Responsibility of Faisal Ibrahim Validation all, Abu Dhabi 11-Mar-16 Vitamin D Deficiency and Human Health Conference, Abu Dhabi Dr. Shereen Atef Vitamin D Assay in Clinical Laboratory: Past, Present and Future Challenges 24-Mar-16 Page 2 of 8
4th Annual Jordanian Society of Medical Laboratory Sciences Congress, Amman Jordan Egyptian Society of Laboratory Medicine meeting, Cairo VPS-Penn Medicine Conference: Integrating Precision Diagnostics into Clinical Care Thyroid Cancer Conference, Abu Dhabi 2nd Abu Dhabi Ambulatory Congress, Abu Dhabi Quality Assurance in Clinical Laboratories Trends, Updates and Innovation, Abu Dhabi Quality Assurance in Clinical Laboratories Trends, Updates and Innovation, Dubai Cervical Pap Tests: Tips for Collection and Sending to the Laboratory, Dubai ASCP Conference Pathology Update 2016, Abu Dhabi Dr. Frank Ryan HIV testing 08-Apr-16 Dr. Frank Ryan HCG testing 19-Apr-16 Dr. Basel Altrabulsi Next Generation Sequencing: from Sample Preparation to Clinical Applications 19-May-16 Dr. Basel Altrabulsi Thyroid Cancer 30-Sep-16 Dr. Basel Altrabulsi Viral Hepatitis 14-Oct-16 Faisal Ibrahim CAP 2016 Checklist Updates 15-Oct-16 Faisal Ibrahim CAP 2016 Checklist Updates 22-Oct-16 Dr. Basel Altrabulsi MOH 27-Oct-16 Dr. Shereen Atef Faisal Ibrahim Dr. Basel Altrabulsi Serum Free Light Chain in Diagnostic Laboratory Cross Walk Between ISO 15189 and CAP - Glandular Lesions of the Cervix Cytology - NGS and Cancer Diagnosis 03-Nov-16 04-Nov-16 04-Nov-16 Photos of QA CME Seminar Provided by NRL: Page 3 of 8
2. Employee Competency / American Society for Clinical Pathology International (ASCPi) Certification Employees are the laboratory s most valuable resource and ensuring their success in a highly-technical, patient-centric laboratory requires hiring qualified and laboratory-educated, technical staff. Technologist certification by the American Society for Clinical Pathology (ASCP) is widely recognized as the gold standard among medical laboratory professionals. Completing the certification requirements defined by the ASCPi demonstrates a commitment, by the technologist, to the clinical laboratory profession and further, it certifies that they have attained the knowledge and competency to perform their responsibilities with a dedication to high standards and to quality patient care. NRL continues to seek ASCP-certified technologists, provide them with opportunities and sustain their knowledge through our continuing education and competency programs which meet and exceed the standards defined by all accrediting agencies. Action/Outcome: NRL was recognized by the UAE Advisory Board of the American Society of Clinical Pathologists International (ASCPi) for having one of the highest numbers of ASCPi certified laboratory professionals in the UAE. 41% of NRL technical staff are certified by the ASCP. 3. New Test Implementation Test menu expansion to achieve enhanced patient quality care and business growth is an area that must be monitored for appropriate management. Patient and client impact, the cost to integrate new tests and the ability to sustain the current test menu are key considerations in this endeavor. The NRL collects and analyzes all relevant data before a test is added to the test compendium to ensure all planned outcomes will be realized. Action/Outcome: During Q4 2016, 17 new tests were introduced into NRL s test menu and are now offered to all clients. Please see the Table below for a list of the additional tests: Test Name 1 Mycoplasma Genitalium, NAA 2 Mycoplasma Hominis, NAA 3 Trichomonas Vaginalis, NAA 4 Ureaplasma Urealyticum, NAA Page 4 of 8
5 Ureaplasma Parvum, NAA 6 Factor V Leiden & Prothrombin (F II) Mutations, Whole Blood 7 Immunofixation (IFE), Serum 8 Immunofixation (IFE), Urine 9 Protein Electrophoresis and Immunofixation, Serum 10 Protein Electrophoresis and Immunofixation, Random Urine 11 Protein Electrophoresis and Immunofixation, 24-Hour Urine 12 CEA, Peritoneal Fluid 13 CEA, Pleural Fluid 14 CEA, Miscellaneous Fluid 15 AFP, Peritoneal Fluid 16 AFP, Pleural Fluid 17 AFP, Miscellaneous Fluid As an effort to monitor NRL s success of new test integration, a new indicator was introduced in 2016 which is described below: 4. In-House vs. Send-Out Tests This new indicator monitor s the precentage of in-house tests versus send-out tests to ensure that NRL s strategic goal continues to focus on assisting health care providers in the management of their patients by assessing turaround time for all tests both routine and esoteric. Testing closer to the patient is the ultimate goal. Performing tests in-house not only improves turnaround time it also improves the security of the sample handling process and can help to decrease pre-analytic errors that could arise during transit such as lost samples and specimen rejection issues which may compromise the quality of the specimen. Furthermore, bringing esoteric tests in-house will assist the technical development of laboratory staff by providing enhanced knowlegde and experience.. Target: A steady expansion of the in-house test menu demonstrating an increasingly higher percentage of tests performed, in-house, year over year. Page 5 of 8
Action/Outcome: During 2016, 98% of tests ordered were performed in-house and 2% were sent- out to referral laboratories. Note: In addition to NRL s Centres of Excellence for molecular testing, anatomic pathology and protein studies, a plan is in development to design and establish Centres of Excellence that will provide comprehensive and specialized testing in the fields of special coagulation, flow-cytometry, and tuberculosis testing that will include the addition of a Biosafety Level 3 laboratory. Furthermore, NRL will integrate an automated mass spectrometry identification system in the microbiology laboratory that will aid in the identification of pathogens and greatly reduce turnaround times. KEY PERFORMANCE INDICATORS 5. Customer Service/Speed of Answering Calls Customer Service responsiveness is pivotal to the success of the laboratory process and; therefore, impacts many of the other key quality indicators. The timely support provided to clients ensures that; for example, the answers to their questions will facilitate more accurate specimen submission and/or process completion. Therefore, tracking and improving processes relative to telephone call abandon rates is an indicator of customer satisfaction. The average time it takes to answer a telephone call is measured in wait time which is defined as the average time, in seconds, that a caller waits/holds, in queue, for a Customer Care Representative. Page 6 of 8
Action/Outcome: Wait time was consistent throughout 2016 with an average of 12 seconds per month signifying that response time is satisfactory for our clients. Wait time in seconds 20 18 16 14 12 10 8 6 4 2 0 Average Wait Time - 2016 12 12 14 13 13 12 12 11 11 11 11 10 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 6. Quality Concerns/Non-Conformities Monitoring The investigation, review and monitoring of nonconformities is an important component of NRL s Quality Management System (QMS). Utilizing the Corrective Action Preventive Action (CAPA) module in NRL s electronic, document control management system, the QA department is able to identify, track and control nonconformities which are internally referred to as Quality Concerns. There are two types of quality concerns; internal and external. Internal concerns are identified by staff within the organization and external concerns are raised by clients and customers. All concerns follow a defined process of investigation, documentation for resolution and improved outcomes where indicated. Identifying the root cause of non-conformities is essential for continuous quality improvement. Monthly Quality Concern Meetings are held with representatives from all departments including management, finance/insurance, business development, technical operations and information technology. The meetings focus on data review and analysis for associated improvement. Their mission is to: - enhance NRL s level of service provided to clients - detect internal errors and identify training or retraining opportunities Page 7 of 8
- determine the root cause of non-conformities and formulate corrective/preventive action plans - monitor the outcome of the corrective/preventive action plans Target: < 0.2% of total monthly test volumes Action/Outcome: Internal and external concerns raised and addressed during Q4 2016 averaged 33 per month. Overall, the number and significance of concerns are in a continuous decline throughout the year. Six Sigma is a quality management system which utilizes a number of specialized measures or metrics. The most fundamental measure of process performance is the Defects Per Million Opportunities (DPMO) measure. The aim of six sigma is to achieve less than 3.4 DPMO which is equivalent to six sigma metrics. Most industries strive for a minimum of three sigma metrics which is considered acceptable. During analysis of NRL s quality concern data, the organization meets 4.84 sigma metrics which is an excellent score for the laboratory industry signifying a 99.96% error free process. Number of Concerns - 2016 70 60 50 40 30 20 10 0 57 57 65 38 40 58 45 52 33 29 36 35 Rate of Monthly Concerns - 2016 0.07% 0.06% 0.05% 0.04% 0.03% 0.02% 0.01% 0.00% Target: less than 0.2% Page 8 of 8