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*AG Abubakar, M Ahmadu, Gideon Tok, O Balogun, A Ojo, I Mamman, N Agala, S Osawe, C , O Oke, T Jelpe, S Peters Institute of Human Virology, 252, Hebert Macaulay Street Central Business district Abuja. *firstname.lastname@example.org
Medical Laboratories are subject to so many national and international requirements geared towards precise and accurate results for the patient‘s safety. This effort along the line has made it extremely diﬃcult and time consuming to track compliance with every individual organization‘s listed requirements. Fortunately, the Clinical Laboratories Standards Institute (CLSI) Quality Management Systems (QMS) model provides a means for aggregating all like requirements from diﬀerent regulatory, accreditation, and standards-setting organizations into an easily understandable matrix. This helpful framework allows laboratories to develop quality and technical policies, processes, and procedures that meet all current regulatory requirements. Understanding the modular framework and using it to implement the activities necessary to meet requirements is the laboratory‘s best and easiest means to ‗‗build quality into‘‘ its daily work in the interests of patient care and safety.[1 ] This could be achieved over a good period of time, through training, mentoring and a step wise attitudinal change. Few developing countries have established laboratory quality standards that are affordable and easy to implement and monitor. To address this challenge, the World Health Organization Regional Office for Africa (WHO AFRO) established a stepwise approach, using a 0- to 5-star scale, to the recognition of evolving fulfillment of the ISO 15189 standard rather than an outright pass-fail grading. Laboratories that fail to achieve an assessment score of at least 55% will not be awarded any star ranking. Laboratories that achieve 95% or more will receive a 5-star rating, making them fully prepared for other accreditations. This stepwise approach acknowledges to laboratories where they stand, supports them with a series of evaluations to use to demonstrate improvement, and recognizes and rewards their progress s. WHO AFRO‘s accreditation process is not intended to replace established ISO 15189 accreditation schemes, but rather to provide an interim pathway to the realization of international laboratory standards. Laboratories that demonstrate outstanding performance in the WHO-AFRO process will be strongly encouraged to enroll in an established ISO 15189 accreditation schemes which is affordable, sustainable, effective, and scalable. Recently, this stepwise approach was demonstrated by our laboratory in Jos, Plateau Virology Research Center (PLASVIREC) which tremendously improved from a two star laboratory to a four star laboratory, within just six months. In sub-Saharan Africa in general, and Nigeria in particular, despite the high cost in laboratory testing, aggravated by a slow implementation of the National Health Insurance Scheme, laboratory infrastructure and personnel are adversely affected by a lack of resources and prioritization, hampering laboratory systems in efforts to fulfill their important role in the fight against infectious and chronic diseases. As a result, the accessibility of laboratory testing and the quality of available services remains a serious challenge. It is therefore imperative that laboratory systems be strengthened within broader efforts toward health system strengthening. Efforts to strengthen laboratory systems in the African region have received increased attention in recent years.  There is no doubt, in Nigeria that the Presidential Emergency Fund for AIDS Relief (PEFPAR) has been supportive in regard. This article discusses the individual elements of the QMS/WHO-AFRO model and how Nigerian laboratories can use the model to ‗‗build in‘‘ a QMS that covers all regulatory and accreditation requirements, prepares laboratories for announced and unannounced inspections, and provides the means for the laboratory to make its best contribution to
patient care and safety. We also made an attempt to provide a step wise approach which will help towards achieving a personnel attitudinal change in the laboratory staff towards building quality into their day to day work.
Laboratory Accreditation and Certification Laboratory certification is a procedure in which a third party gives formal recognition of QMS, most commonly ISO 9001; it does not guaranty the actual technical competence of a laboratory.  Accreditation is a formal recognition of technical competence in addition to compliance with QSM. Two key features of accreditation are external review and regular external audits by an external independent body and fulfilling requirement standard, a good example ISO 15189 and ISO 17025. Comparative Advantages of WHO-AFRO Accreditation Gershy-Damet (2010) and others also pointed out that the WHO-AFRO laboratory accreditation process has 4 key comparative advantages: accessibility, affordability, scalability, and sustainability. Like the process itself, these advantages build on each other in a stepwise manner. Accessibility The stepwise approach they described above makes the WHOAFRO accreditation process accessible to public sector laboratories at various levels of development. Rather than deferring participation until the requirements of ISO 15189 are in place, countries can enroll in the WHO-AFRO program now and, through it, track the achievement of their laboratories toward upper-tier status. The WHO-AFRO program benefits countries that lack an established national accreditation body and/or find that the services of international and regional bodies may not yet be easily accessible. Affordability The WHO-AFRO accreditation process is available to countries free of charge, eliminating a critical barrier to enrollment. This enables health officials and policy makers to begin to immediately develop national strategic plans that prioritize accreditation across their laboratory networks without undue financial constraints. To address other key costs encountered in the drive to accreditation, WHO AFRO will provide member countries with free proficiency testing (PT) services from a center currently being established in Senegal, and affordable calibration services are also being developed. These services will complement the WHO-sponsored PT panels currently provided to member countries. Rather than paying for external services, countries should instead dedicate their resources to strengthening laboratory quality systems. Scalability The accessibility and affordability of the program make it scalable for countries in the African region. The stepwise approach and limited cost to the user make it feasible for ministries of health to develop plans that, for example, involve their regional, provincial, and district laboratories in the within a few years. Sustainability Each of the 3 previously described advantages make the WHO-AFRO program a sustainable means for promoting laboratory accreditation. For those minding budgets, afford-ability may be the most important factor in the year-over-year viability of the program. However, the scalability of the program enables the development of vital experience in the operation of laboratories striving toward accreditation across a greater number of laboratories. This will build a broader experience base in the laboratory workforce that will aid the cascade and consolidation of national efforts. This experience base will aid the longer term development of national laboratory experts who can contribute to and lead regional and national accrediting bodies. These advantages—accessibility, affordability, scalability, and sustainability—position the WHO-AFRO laboratory
accreditation process to have a marked influence on improving the quality of laboratory systems in the African region during the next 5 years.
Building Blocks of the Accreditation Process There are several key building blocks of the accreditation process: (1) the role of WHO AFRO, (2) standards and assessment tools, (3) assessors and assessor training, (4) equipment calibration and biosafety, (5) laboratory management training, and (6) a PT provider. The Role of WHO AFRO Few countries in Africa have their own accrediting body for ISO 15189. Although not an accrediting body, WHO AFRO has established this stepwise accreditation process for medical laboratories in accordance with the WHO mandate to ―develop, establish, and promote international standards with respect to food, biological, pharmaceutical, and similar products‖ and the WHO AFRO efforts to strengthen the tiered laboratory systems of its member states. In this capacity, WHO has accredited laboratories for important diseases, including polio, measles, and influenza, and HIV drug resistance monitoring. Accreditation will be a crucial capacity-building focus of the WHO AFRO–supported Laboratory Network. The governance structure of the WHO-AFRO Laboratory Network includes a technical advisory group on laboratories that will provide oversight of the accreditation process and advise the WHO-AFRO secretariat on laboratory capacity building in the African region. Standards and Assessment Tools The WHO-AFRO laboratory accreditation process is based on ISO standard 15189:2007(E). The process is accessible to ministries of health for all laboratories providing clinical testing services. The accreditation checklist is organized into headings similar to the Clinical and Laboratory Standards Institute Quality Systems Essentials. These 12 areas of assessment cut across both sections of the ISO 15189 standard (management and technical requirements) and help to facilitate the inspection process .The accreditation checklist evaluates areas common to ISO 15189 and other laboratory standards, such as ISO 17025, the evaluation criteria of the CAP, and the standards Thailand‘s Medical Technology Council developed for use in Thailand . The checklist‘s 12 sections provide assessment on the basis of 110 clauses and 250 total possible points. Each item has been assigned a weighted value of 2, 3, or 5 points based on complexity and/or relative importance. Incomplete fulfillment of an item can be scored as ―partial‖ and awarded a single point, with written explanation. Some clauses in the checklist are ―tick lists‖ and require the satisfactory presence of all subitems listed below the main heading to receive full credit. Baseline assessments using the WHO-AFRO checklist can be analyzed and presented as a gap analysis for national accreditation efforts, revealing facility-specific challenges and systemic areas of need that must be prioritized and addressed. Over time, progress in strengthening laboratories can be tracked by comparing assessment findings. In Lesotho, the WHO-AFRO checklist has been used as a monitoring tool to evaluate laboratories receiving mentoring support; these assessments have already helped to quantify and demonstrate areas of laudable progress and continuing challenge. Assessors and Assessor Training Accreditation will be awarded based on biannual assessments of laboratories conducted by assessors selected and trained by WHO AFRO. These assessors will be drawn from laboratories across sub-Saharan Africa. Assessors are being trained in 2 training centers, one in Kenya for English-speaking assessors, and the other in Cameroon for Frenchspeaking assessors. Assessor teams will be led by a team leader, and their size and composition will vary based on the scope of the laboratory seeking accreditation. Assessors will not be permitted to assess laboratories in their country of residence and will not be financially compensated.
Calibration and Biosafety
Proficiency Testing . WHO AFRO. will provide training on equipment calibration and biosafety for countries engaged in the accreditation process. Uganda.WHO AFRO. South Africa.and competency-based training and mentoring tool kit jointly developed by the CDC. and the American Society for Clinical Pathology that equips laboratory managers preparing for accreditation. in close collaboration with the African Field Epidemiology Network Laboratory in Kampala. The SLMTA training tool kit is well suited for use by mentors in facility-level work. to build national training teams for SLMTA in 12 countries including Nigeria (with 12 trained assessors). Laboratory mentors who spend extended well-structured periods embedded in the daily life of a laboratory are also a valuable means of accelerating a laboratory‘s path toward accreditation. Assessment Section Documents and records Management reviews Organization and personnel Client management and customer service Equipment Internal audit Purchasing and inventory Information management Process control and internal/external quality assessment Corrective action Occurrence/incident management and process improvement Facilities and safety Points 25 12 20 8 30 10 30 14 43 Table Health for Africa Points for Section 1.Sections of the World Organization Regional Office Accreditation Checklist and Each 8 10 40 Total 250 Laboratory Management Training and Mentoring Strengthening Laboratory Management Toward Accreditation (SLMTA) is an innovative task. SLMTA begins with baseline assessments with the WHO-AFRO checklist and uses a multiple workshop model with supervised improvement projects conducted between trainings. A series of training sessions has been held at the African Center for Integrated Laboratory Training at the National Institute for Communicable Diseases. Johannesburg. the Clinton Health Access Initiative.
including serology. and quality improvement. National Institute for Communicable Diseases.CD4. Following assessment. Digital PT. from pre-analytical through post-analytical procedures. This program is not intended to replace established ISO 15189 accreditation schemes. the WHO-AFRO approach provides laboratories with stepwise recognition of evolving fulfillment of the ISO 15189 standard rather than binary pass-fail grading. blood chemistry and rapid testing. and recognizing improvement toward the realization of international laboratory standards and subsequent application to full ISO 15189 schemes. South Africa.400 MLSCN IHVN PT Quarterly 76 CDC WHO/EQUAP Japan PT(Atlanta) Retesting (Nigeria) PT Quarterly Once a year Twice a year 18 1 Specific Criteria: In addition to the 12-section. monitoring. HIV serology HIV Serology. some implementing partners and the Medical Laboratory Council are preparing PT panels for hematology. quality control. The WHO-AFRO Stepwise Accreditation Approach Recognizing the gap between the current state of laboratories and the requirements of ISO 15189. 250-point assessment checklist. MA. and parasitological testing. Some External Quality Assurance programs currently in Nigeria Organizing Agency Axios Type of activity Supporting PT panels distribution from South Africa PT Intervals Monthly and bimonthly Twice a year Specialties covered HIV serology and CD4 Haematology. TB smear HIV-1 DNA DBS Influenza Molecular Diagnosis Number of Laboratories Involved 81 and 64 respectively 1.to 5-star ascending scale. Haematology. characterized by strong programs for quality assurance. as are laboratory safety and ethics. several specific criteria are required to receive recognition in the WHO-AFRO accreditation process. All testing areas and processes are included. hematology. Westford. but rather to provide an interim pathway for measuring. chemistry. Table2. The WHO-AFRO accreditation process provides a framework to establish an effective quality management system for medical laboratory testing. CD4. chemistry. and National Health Laboratory Services. chemistry.The Department of Bacteriology and Virology of the Dantec Hospital. Laboratories that achieve 95% or more will receive a 5- . laboratories will be recognized on a 0. In Nigeria. will provide comprehensive PT for several analytes. The accreditation process will also accept PT programs by other recognized providers. Laboratories that fail to achieve at least 55% on assessment will not be awarded a star ranking. Dakar. microbiology.
Technical support . supports them with a series of assessment opportunities. and establishes a mechanism for tracking progress toward these goals. Once assessed. This stepwise approach acknowledges laboratories where they stand. laboratories are expected to maintain their star status and work toward the next star. and recognizes and rewards progress over time. The WHO-AFRO program benchmarks current performance. Laboratories awarded 5 stars will be strongly encouraged to enroll in an established ISO 15189 accreditation scheme. evaluates the distance remaining to achieve international standards.star rating Figure1 below.
and post-analytic activities (reporting results.will be intensified by AFRO and partners to help countries meet their accreditation goals. South African Development Community Accreditation Service.33] . based on 1 to 5 stars. ISO. South African National Accreditation System Clinical Laboratories Standards Institute (CLIS) simple model for a laboratory quality system: As mentioned earlier. error-free. or SADCAS accreditation. interpretation). it is the job of the laboratory supervisory and managerial staﬀ to design and implement the supportive infrastructure that is necessary for the technical work to proceed unimpeded. It is the job of the laboratory technical staﬀ to perform pre-analytic activities (blood sample collection. Importantly. archiving samples. The program is expected to have a catalytic effect. ISO. CAP. sensitizing policy makers and laboratory staff on accreditation. Fig. Joint Commission International. unimpeded realization of highquality. this ﬁgure also represents a QMS model that can be used in the medical laboratory environment. The CLIS. and nurturing the development of laboratories in the African region. model is pertinent to achieving this goal. but to serve as an accreditation scheme to assist the laboratories in obtaining these internationally recognized accreditation standards. World Health Organization (WHO) Regional Office for Africa (AFRO) accreditation scheme showing the stepwise recognition of laboratory performance. A good team work between technical and managerial activities is essential for the continuous. Laboratories that have attained the 5 star grading are encouraged to enroll for ISO 15189. charge capture) that transform a clinician‘s request for a laboratory test or examination into the results used by the clinician to diagnose and treat patients. and eﬀective laboratory operations. The purpose of the WHO-AFRO accreditation is not to replace CAP. receiving. examinations. SANAS. Figure 1. Laboratories that receive a 5-star rating are strongly encouraged to transition to an internationally established accreditation scheme. College of American Pathologists. eﬃcient. SADCAS. Likewise. SANAS. laboratories are assigned an accreditation level. analytic activities (testing. accessioning). International Organization for Standardization. encouraging the incorporation of accreditation goals into national strategic and operational plans.[1. Based on the percentage score. JCI. Medical laboratory work is composed of the technical activities that produce laboratory results for patient care and the management activities that support the technical work. 2 depicts this important relationship between technical and managerial activities.
• The speciﬁc pre-analytic. it needs to identify its potential customers and determine their needs and expectations for the new service. The QMS is a uniform. Before a new testing can be performed. however. and put in place for the new service. • Next. analytic. every day. obtained. the laboratory must determine the responsibilities and reporting relationships of all the people involved in the new service. • First. • Staﬀ needs to be trained and their initial competence assessed. 4 Implementing a quality management system: Most laboratories are already performing management activities that comprise components of a QMS. validated. CLSI approved guideline HS1: a quality system model for health care. and documented. sought. • Next.Quality System Essentials (QSEs) Documents and Records Organization Personnel Equipment Purchasing and Inventory Process Control Information Management Occurrence Management Assessment: External and Internal Process Improvement Customer Service and Satisfaction Facilities and Safety Fig. 2nd edition. Wayne (PA): 2004. people. laboratory management must implement a number of critical infrastructural elements in a logical sequence and ensure they are solidly in place. equipment. and post-analytic work processes and procedures need to be developed. analytic. not all necessary management activities are practiced in every laboratory and those that are may not be practiced uniformly within a single laboratory. p. the speciﬁc pre-analytic. and post-analytic work processes and procedures for the new testing need to be identiﬁed. every time. systematic means for any laboratory to ensure that requirements are being continuously met each time. The resulting variation in management practice causes ineﬃciencies in the use of resources and ineﬀectiveness in meeting accreditation and regulatory requirements. • The laboratory needs to determine the means by which patient results and reports will be managed for . Without a standardized QMS in place. 2. and materials need to be identiﬁed. in every laboratory section. • Then. adequate facilities. A simple generic model for a quality management system (From CLSI.
• The laboratory needs to determine how it will measure its performance to determine if goals. . • There is need to determine the laboratory’s means for capturing complaints and non-conformances for the new service. • The laboratory needs to determine the means by which quality reports will be periodically prepared for the new service. • Last. objectives. and customer expectations are being met for the new service. the laboratory needs to determine how management will review and identify opportunities for process improvement and prioritize and initiate improvement activities.the new service.
and procedures for the QSEs shown in Fig. and (3) measurements. This modiﬁcation is shown in Fig. Wayne (PA): 2004. 3. Every essential component needs to be in place for the laboratory to create and maintain its complete structural integrity. whole organization. Fig. Arrangement of the quality system essentials of the QMS model into logical groupings. One way to depict this important sequence of managerial events is by slightly modifying the QMS model as ﬁrst shown in Fig1. CLSI approved guideline HS1: a quality system model for health care. (Adapted from CLSI. 2 which depicts the QSEs as divided into three groups: (1) laboratory. 2nd edition. 3. with permission. processes.Only after all these elements are ﬁnally in place and functioning. following the prescribed sequence of the three groupings. These three groups sequentially embody the entire laboratory as a dynamic. (2) work.) . The laboratory can implement its entire QMS by establishing the policies. may the new service testing ﬁnally begin.
All personnel roles. layout. should culminate in the laboratory‘s prioritization of opportunities for improvement. and reporting relationships Quality planning and risk assessment Budgeting of resources Quality review and assessment Management review The scope of all of the laboratory‘s services should be clearly documented.16–18]. stated goals and objectives.This sequential approach is also eﬀective when planning any new laboratory service. Facilities and safety The laboratory needs to have adequate space and facilities that are designed and constructed or renovated to optimize work eﬃciency. or when regionalizing any two or more laboratories within the same health system. visitors. the elements of each QSE are individually described next. with a description of all testing services provided and all customers served. or new processes and procedures. or in published standards. equipment. Listed next are several structural and nonstructural elements of laboratory design that aﬀect the planning. Allocation (ie. and applicable requirements [12. The laboratory quality system essentials Organization The laboratory needs to be legally identiﬁable and have a documented organizational plan and structure that ensures the delivery of quality services to patients and all clinical personnel responsible for patient care and ensures patient safety. protect workers. and patients from recognized hazards. A QMS requirement is that laboratory management periodically reviews the eﬀectiveness of the QMS in meeting customer needs. and material resources is necessary for ensuring that resources provide adequate capability to meet customer needs. management review. modiﬁed. minimize the risk of injury and occupational illness. responsibilities. allocation of resources to carry out the improvements. and monitoring of improvement activities to ensure their eﬀectiveness. and reporting relationships need to be documented and communicated so that all staﬀ members are aware of their respective places in the organization. and meet governmental or industry standards for facilities and environment. human. as speciﬁed by regulatory agencies. This last activity. Each element represents a laboratory requirement. budgeting) of facility. responsibilities. Quality planning and risk assessment should be undertaken to ensure that all applicable accreditation and regulatory requirements are met with the laboratory‘s current. or when creating a new entity through mergers. . To clarify the QMS sequential model further. accreditation organizations. This plan and structure should include: • • • • • • Scope Roles. and safety of the laboratory .
Physical and procedural safety is an inseparable adjunct to the physical facility.23] Radiation safety (where applicable) [13. Ensuring clean work areas and good housekeeping involves laboratory staﬀ and ancillary services provided by the larger organization. trained. and materials derived from patient samples. patient samples.24] Ergonomics  Supportive safety training is required in each respective program for each staﬀ member as is applicable to his or her respective job tasks. weather.• • • • • • • • • • Space Workﬂow Casework Equipment placement Classiﬁcations Ventilation Lighting Plumbing Electrical Communications Arrangements are needed for routine maintenance to keep the facility in a functional. The laboratory should have adequate space for storage of consumable supplies. moderate-complexity. . and competent staﬀ performing the work processes. such as tissue blocks and retained slides. the laboratory‘s personnel is the next important resource to be established. The job titles for which these national personnel standards exist are shown in Table 2. disaster) Universal precautions  Hazardous waste  Chemical hygiene  Infection control  Occupational injury and illness [20. reliable. quality laboratory performance cannot be ensured. without qualiﬁed. and safe condition. The Clinical Laboratory Improvement Amendments of 1988 regulation  speciﬁes the minimum requirements for the qualiﬁcations and responsibilities for personnel performing provider-performed. reagents and chemicals. and high-complexity laboratory testing. Certainly. Several safety programs that are required in the laboratory are • • • • • • • • Emergency preparedness (ﬁre. Personnel Once the organization structure and responsibilities have been established and the laboratory‘s physical space needs have been addressed.
consulting pathologists. or split samples.Laboratories and their parent organizations may set additional or higher qualiﬁcations and responsibilities. Suggested elements for laboratory orientation are as follows: • • • • • • Laboratory quality policy Laboratory‘s vision and mission Laboratory values Laboratory goals and objectives Personnel qualiﬁcations and responsibilities Laboratory culture All staﬀ needs training in the work processes and procedures that comprise their respective job tasks. Table 3. whether or not new staﬀ members arrive with previous experience. All personnel qualiﬁcations and responsibilities can be documented in the laboratory‘s job descriptions. such as those from previously tested patients. and technical consultants (for which the laboratory is assessed at its periodic unannounced inspections) have been published by the College of American Pathologists . Job titles for which there are Clinical Laboratory Improvement Amendments of 1988 personnel standards Provider-performed microscopy Laboratory director Testing personnel Moderate-complexity testing Laboratory director Technical consultant Clinical consultant Testing personnel High-complexity testing Laboratory director Technical supervisor Clinical consultant General supervisor Testing personnel Cytology general supervisor Cytotechnologist . if so desired. Qualiﬁcations and responsibilities for the laboratory director. which must be kept current and available to all staﬀ. inter-laboratory comparison materials. The laboratory should provide an induction for all new laboratory staﬀ. The required ways to ensure that competence of staﬀ is assessed and documented initially after training and periodically thereafter are listed as follows [17.25]: • Direct observation of routine work processes and procedures • Direct observation of equipment maintenance and function checks • Monitoring the recording and reporting of test results • Review of work records • Assessment of problem solving skills • Use of specially provided samples.
17]. performance records provide objective evidence of outcomes of these required activities. The laboratory should establish selection criteria for each piece of equipment it needs to acquire. Records of personnel participation in internal and external continuing education and development should be maintained in personnel ﬁles. and personnel are in place. Reconstruction of the history of each piece of equipment from acquisition to decommission should be traceable from the equipment records. and repair records are also required. laboratory staﬀ must also collaborate with the parent organization‘s human resources department for other required activities. and calibration veriﬁcation. . Equipment Once the laboratory‘s organization. such as occupational immunizations. humidity. Records of the laboratory‘s continuing education program are required. In addition to the processes described previously. The processes. calibrations. the laboratory should formalize its needs and requirements in documented agreements with vendors that specify each party‘s responsibilities. water type and quality. and any other special requirements. Troubleshooting. instruments and analytical systems. and wage and payroll registration. and computer systems hardware and software. the laboratory needs to acquire the equipment necessary for delivering its desired testing services. and adjusted as necessary. Before equipment is selected. the laboratory needs to verify that the laboratory‘s physical facility can meet the equipment‘s needs for space and load bearing. electricity. facility. each piece of equipment needs to be installed and initially veriﬁed as meeting the manufacturer‘s stated performance characteristics. the equipment must also be veriﬁed as functioning as intended in the actual work processes in which it is used. and temperature. and should determine which vendors can meet those criteria. ventilation. laboratories are required to provide programs for continuing education and professional development [12. and procedures described for this QSE refer to the laboratory‘s general equipment.To ensure that laboratory staﬀ remains current in job and professional knowledge. the laboratory needs to identify and purchase all related materials and reagents. These agreements should be periodically reviewed to determine the vendor‘s ability to meet the laboratory‘s needs. and before use. Laboratory schedules and procedures that follow manufacturer‘s instructions are required for ongoing preventive maintenance. After arrival. such as equipment maintenance and service contracts and referral laboratory testing. service. For these purposes. The laboratory may also need to purchase services. programs. accident reporting. Purchasing and inventory Before any testing in any new laboratory or new process can begin. After the onset of the actual testing.
In processes where laboratory testing is performed. test method veriﬁcation is also required. Several guidelines are available to assist laboratories in such veriﬁcation of test methods. and determine if the pre-established criteria set for the process have been met and whether the needs of the customers of the process have been met. Such process control begins with identifying and documenting the laboratory‘s many work operations. The laboratory needs to maintain a cost-effective disposable supply inventory and have the support of an adequate materials purchasing program. Laboratories are now required to control their documents and records through the processes listed next [6. personnel. the laboratory must verify that the manufacturer‘s stated speciﬁcations are being met with the laboratory‘s own processes. Veriﬁcation consists of creating a plan that allows the technical staﬀ to challenge the process as initially developed. analytic. evaluated. Documents and records At the heart of the laboratory‘s QMS are the policy. and tested as necessary (before use) to ensure that necessary quality requirements have been fulﬁlled. the process and procedure documents conveniently form the basis of the technical procedures manuals. Use of properly constructed process ﬂowcharts eﬃciently identiﬁes the activities for which procedures (ie.Eﬃcient laboratory operations require the uninterrupted availability of reagents. and materials. supplies. The use of statistical tools provides a visual means to understand quality control data so that timely action can be taken when method problems are detected . and post-analytic work processes is crucial to the quality of the laboratory‘s test results. or contain incorrect information. and procedure documents that tell staﬀ what to do and how to do it and the records that provide objective evidence of the results of performing the processes and procedures. instructions) are needed for the laboratory staﬀ to perform their assigned job tasks. Critical reagents and materials need to be received. Before any process is executed in the live environment. The work quality system essentials Process control Control of the laboratory‘s pre-analytic. and services. outdated. equipment.8. Also. both the minimum required quality control  and any manufacturer‘s requirements must be followed. Quality control programs are a means of controlling patient testing processes at the bench level. incomplete. process. A concise guide of laboratory processes with examples is available . Laboratories must meet the established requirements for quality control of test methods. Audits often reveal that laboratory documents and records are missing. Such process analysis expedites the writing of individual procedure documents. document the results. all these problems can cause errors that could compromise patient safety. Together.9]: . the process needs to be veriﬁed as meeting its intended outcome.
there needs to be a downtime program for managing the availability of patient results and information when the computer system is not functioning. and approval of new documents Document master ﬁles Review and approval of changes to approved documents Periodic review of unchanged documents Master index of documents Document distribution Archiving. reports. requests for information. and data integrity (eg. test results and interpretations. other laboratory data and information. .Document control elements Document identiﬁcation Creation. electronic interfaces and data transfer). conﬁdentiality of information. Also. The laboratory needs to have policies. In addition. information transfer (eg. report readability and accuracy). provided that only the most current documents are available to all staﬀ at the locations where they are needed for staﬀ to perform their assigned job tasks. storage. and procedures that address information access and security. review. processes. This includes patient demographics. and how that information is disseminated to users or other computer systems. Information management The requirements contained in this QSE concern the laboratory‘s management of the information contained in its paper-based or computer-based record systems. this QSE contains the requirements for the processes to ensure against Medicare and Medicaid charging and billing fraud and abuse . and retention of obsolete documents Record control elements Record identiﬁcation Creation and legibility Records reviews Record indexing Records access Changes to recorded information Record storage and retention Record disposal Either or both paper or electronic document control systems are acceptable.
and the needs of the laboratory‘s customers. First. or Commission on Oﬃce Laboratory Accreditation. The program captures and analyzes information about nonconforming events and complaints to identify underlying systematic problems and gain management‘s commitment to removing the causes. The remaining four measurement QSEs shift the focus to asking and answering the question of how well the laboratory‘s processes are performing in meeting the quality goals and objectives set in QSE: Organization. The laboratory should be participating in three types of external assessments: (1) licensing or accreditation. or other imposed requirements. eight QSEs (presented in sequential terms of ‗‗laboratory‘‘ and ‗‗work‘‘) have described the actions needed to prepare for the laboratory‘s production of testing and examination result reports. such as the Joint Commission. .‘‘ this QSE consists of the requirements for documenting and investigating events that do not conform to the laboratory‘s established policies. Assessments: external and internal The laboratory cannot improve the quality of its services without measuring its current performance. all laboratories are subject to external assessment by licensing agencies (eg. Centers for Medicare and Medicaid Services. College of American Pathologists. under the Clinical Laboratory Improvement Amendments of 1988) or accreditation organizations. These are the QSEs of ‗‗measurement. or procedures. and (3) performance comparison. These organizations assess the laboratory against their respective published requirements and issue deﬁciencies for identiﬁed nonconformances that require subsequent corrective action for the laboratory to maintain the license or accreditation.The measurement quality system essentials Up to this point. Both external and internal assessments provide objective evidence of the laboratory‘s performance compared with established goals. the requirements imposed by regulatory agencies and accreditation organizations. processes. (2) proﬁciency testing.‘‘ Occurrence management Now referred to as ‗‗nonconforming event management. A nonconforming event management program contains the following elements : • • • • • • • Identiﬁcation and reporting Remedial action Investigation and documenting Action plan Classiﬁcation Analysis and presentation Management review and follow-up This QSE also includes the recently established requirement for the laboratory to have a process for employees to communicate concerns about quality and safety to laboratory management .
with feedback provided. and reports to its clinical caregiver customers. 17]. laboratories that perform referral testing have other laboratories as external customers. or management process can be audited to determine its conformance to the laboratory‘s established policies. In the laboratory environment. Routinely. Adequate measurement and monitoring of laboratory performance requires feedback being actively. One example is the number and source of received samples that do not meet the laboratory‘s established acceptance criteria. The third type of external assessment involves the laboratory‘s comparison of its performance on selected process measurements against other laboratories of similar size and scope. post analytic. analytic. records of clinical meetings is good examples of what a good assessor will look out for under customer satisfaction. The referral laboratory should routinely assess these other laboratory customers‘ satisfaction with its referral services that includes the performance of any couriers. interpretations. A laboratory audit is the process of comparing observations of actual conditions with requirements and presenting an evaluation of the results to management . the results of which are compared with other laboratories with similar methods and instrumentation . and external regulatory and accreditation requirements. such as control charts. College of American Pathologists inspectors are using (vertical) auditing techniques to ‗‗follow the sample‘‘ through the laboratory‘s processes during unannounced laboratory inspections . questionnaires. Quality indicators are measurements of process performance that are tracked using graphical tools. processes. another is turnaround time. Ideally. the laboratory identiﬁes one or more indicators to measure the performance of its pre analytic. and post analytic work processes. Also. analytic. call centers. . laboratories should practice two types of internal assessments: quality indicator measurements and laboratory audits. The satisfaction of the laboratory‘s internal (employee) customers should also be periodically assessed. Audit ﬁndings point to process problems that need corrective action. routinely solicited from these customers regarding their satisfaction with the laboratory services they have received . any pre analytic. where the laboratory tests or examines sample materials prepared and sent by an outside organization. Suggestion box. Customer service The laboratory provides phlebotomy services to patient customers and provides test results. Many examples of laboratory indicators are available [10. The College of American Pathologists maintains two such programs: Q-PROBES and Q-TRACKS .The second type of external assessment is proﬁciency testing. and reports involved. and procedures.
processes. Quality tools from the nonmedical manufacturing arena have been adapted to improve health care processes. This process needs a lot technical expertise. analytic. analyze. analytic. 29]. . or failures. cost. so that compliance with requirements and with factors critical to customer satisfaction can be achieved . often without additional resources [20-23]. improve. internal quality indicators. probability of occurrence. and frustration associated with the existing health care system . such as quality control. The laboratory needs to prepare information from measurement activities into a periodic report that is reviewed by laboratory management. The ﬁve major activities of any Six Sigma project (deﬁne. care has to be taken not to compromise professionalism. Lean. Medical device manufacturers and industry consultants now oﬀer Lean consulting services because many laboratories realize that a more eﬃcient throughput means an increase in the laboratory‘s capability for more testing. specialization and thrive for excellence.4 defects per million opportunities. and tracking to tie together quality. calculated. overcrowding.Process improvement Measurement and monitoring of laboratory process performance points to opportunities for improvement. ﬁrst practiced and then formalized into the Toyota Production System . and control) include measurements. While this approach sounds good to the mangers and employers of services in cost cutting. team work between the laboratory and clinical groups and everybody has at an alert for reviews. and severity of outcome are assigned. with prioritization of problems for improvement and allocation of resources for these improvements. Comparisons of error rates for selected laboratory pre-analytic. performance comparisons. Six Sigma methodologies have been successfully applied in the automated laboratory environment  and to health care in general . Several diﬀerent quality tools are available for determining the root cause of the problems and identifying potential solutions. statistical analysis. Six Sigma is a methodology that uses proved quality principles and techniques to reduce process variation and decrease errors toward the 6s level of 3. quality audits. Process adjustments are made to reduce or remove the risks and improve the outcome. nonconforming events. and customer satisfaction feedback provide information that points to pre analytic. and accountability. Scores for likelihood of failure detection. proﬁciency testing. Lean is a work philosophy that strives to eliminate waste from a process. including Failure Modes and Eﬀects Analysis. and post-analytic processes demonstrate that laboratory processes have yet to achieve the Six Sigma goal [28. measure. people. This method will surely work with realities on ground and will keep all hands on deck towards achieving zero tolerance to error in clinical laboratories. external assessments. and post analytic processes that are currently problematic or have the potential to become problematic if no preventive action is taken. and Six Sigma: Failure Modes and Eﬀects Analysis is a tool used to analyze the activities in a process for points of vulnerability. and prioritized. Lean tools and principles are also being actively applied to eliminate delays. Improvement teams should be convened and assigned to speciﬁc problems for solution. All measurement activities. potential and actual risks.
Likewise. and Plan-Do-Check-Act programs popular in the 1990s has solved the problems of medical errors causing patient injury and death so clearly documented in recent history. such as the previously described 12-QSE model. Measurement and monitoring activities provide objective evidence of process performance. none of the Total Quality Management. Unfortunately. These.(Patient Safety Monitoring & International Laboratory Evaluation) has been supportive to many developing countries. These laboratories have reported signiﬁcant decreases in the numbers of deﬁciencies found during accreditation inspections and decreases in the cost of process failures. Laboratory management takes visible. measurement.31]. however. and Internet reports. customer considerations. Edmonton. as reported in health care journals. before implementation. Laboratory management actively reviews reports of process performance. This model is generic and applicable to laboratories of any size. analytic. Most laboratories use these quality tools only for identiﬁed problems. What many laboratories lack is a fundamental foundational approach to quality in which the desired level of quality and process performance are built into each laboratory process such that [32. A number of United States and Canadian laboratories have successfully used the model for implementing quality management as a means to achieve process improvement and patient safety and readiness for unannounced laboratory inspections. or specialty anywhere in the world. These three tools can also. . Numerous opportunities for individuals to become certiﬁed in Lean and Six Sigma methods are available for laboratorians so interested. such as errors made at sample receiving (Sutter Health Sacrament-Sierra region and University of Alberta. every time. personal communications. and improvement is that of implementing a QMS. and post-analytic activities. Incremental quality tools versus systematic quality management The 12 QSEs comprise a systematic approach to quality management that ensures the laboratory meets all applicable requirements as part of performing everyday pre-analytic. Lean. instead of being incorporated into a system for quality. there is a pervading assumption that Failure Modes and Eﬀects Analysis. laboratory periodicals. process design. patient safety. scope. applied in QSE process control when the laboratory develops a new process (eg. an Internet search provides ample information. thereby missing the opportunity to have initially designed. however. are merely single tools for improving only one work process at a time. Applications of this subject continue to grow. and post-analytic workﬂow. the aforementioned tools do indeed eﬀect improvements) but rather that these tools have been used in isolation. which supports the laboratory‘s entire path of pre-analytic.33] • • • • All applicable requirements and customer needs are met the ﬁrst time. analytic. It has also been deemed simple enough to have been adapted for use in African countries supported by the President‘s Emergency Program for AIDS Relief . monitoring. pSMILE . continuous Quality Improvement. validated. It can be argued that the reason for these failures has not been within the tools themselves (used properly.Combinations of Lean and Six Sigma methods have been applied to both health care processes and the medical laboratory [30. and should be. and Six Sigma alone solve the quality problems of both laboratory and health care services. May 2007). deﬁnable actions to remove root causes. the example of adding a new testing service to diagnostic testing). documented. The approach that most successfully integrates all regulatory and accreditation requirements. and implemented the processes optimally to identify any and all problems that actually arise.
turnaround times. and procedures for the QSEs. quality indicators. analytic. it may be more efﬁcient to perform segmental MRs. There is a lot of work for the pathologists which include point of care testing. Laboratory scientific/administrative management should focus on setting the policies. buffering the gap between scientists and physicians for instance establishing precise and accurate determination of reference values. EQA. lacking either. status of preventive and corrective actions. and procedures for the pre-analytic. ‗laboratory management shall review the QMS to ensure continuing suitability and effectiveness in support of patient care and to introduce any necessary changes or improvements. However.15. The standard states that an MR typically occurs once every 12 months. interpretation of laboratory results to clinicians. The results of the review shall be incorporated into a plan that includes goals. The equally important role of the pathologist medical partnership/leadership is to ensure that the policies. QSE and path of workﬂow activities require the constant collaboration of both scientific and medical leadership. removing barriers that prevent staﬀ from getting their respective tasks accomplished eﬃciently and eﬀectively. previous MRs. quality becomes relegated to the minimum required practice. and post-analytic work ﬂow meet technical requirements and produce clinically relevant. Two types of leadership exist in most laboratories: medical leadership and scientific leadership. Leadership sets the tone and culture for quality in any organization. critical values and management of pathological conditions of the patients to mention but a few. 4. accurate results and interpretations to the laboratory‘s customers for the purposes of patient care.1). leadership is the key ingredient in organizational quality improvement. but they should still aim for continuous improvement. internal audits and external audits. and all testimonials of Malcolm Baldrige award-winning organizations. quality literature. The QMS model described in this article provides the roadmap in which this collaboration can successfully provide the laboratory‘s best contribution to patient care and safety. NCs. Both are needed to support a sustainable culture of quality management in the medical laboratory environment. feedback and evaluation of suppliers. complaints. Questions to be asked (and answered) include the following: ‗Do we still support our objectives and quality vision?‘ and ‗Are we still satisﬁed about the way certain elements of the QMS are implemented?‘ The management should dare to change directions or lower criteria when initial objectives are too ambitious. in some laboratories. such as the results of IQC. Emphasis should be on developing an overview of the many elements of a QMS. Management review: • According to the accreditation standards. Staﬀ looks to leadership for guidance and follow-through and.Sustaining a culture of quality in the medical laboratory From all accounts in the nonmedical industry. ensuring that by the end of the year all elements are • • • • • . processes. processes. objectives and action plans‘ (ISO 15189.
a good preparation is essential. All this information should be written in a report that is absolutely necessary. The outcome of the MR should include an action plan (‗what. One way to prepare for the meeting efﬁciently is to have a meeting in advance with all the people who will collect data. Start with some positive elements. and should be informed about the outcome and the action plan. ﬁnished within a reasonable time. All people working in the laboratory can help to collect data where appropriate. • • • • Collected data are then provided to the management before the meeting in a structured manner. which form the input of the MR. To facilitate a successful MR. Use a logical structure. an MR is a process in which the whole laboratory is involved. When this program identiﬁes opportunities for improvement. The quality manager is responsible for the follow-up of the action plan. the quality manager or laboratory director chairs the MR. in an understandable and meaningful way. This leads to an MR meeting focused on the right topics. show solutions. Listen actively and verify that everybody understands and agrees. In other words. invites the participants of the meeting (management or staff and usually the quality team members) and contacts the people in the laboratory responsible for collecting the necessary data summarized above. to standardize the way the results are presented by different groups. but keep focus and respect the timing. or at least share a template ahead of time. In addition. Usually. to present the information. All laboratory staff is informed of the results of the review. The report is dated and signed or approved afterwards. Quality indicators are important input elements used in an MR. resource needs or important decisions could be enclosed. The whole process is driven by the management. Finally. who and by when?‘) and the objectives of the next year. the techniques of motivation and change management (see further) could be applied. but they can delegate tasks to the quality manager to collect all the data. but is not the only person who talks. • As the information discussed during the MR is extensive. Difﬁcult or technical subtopics could be addressed in a separate meeting with fewer participants.tackled. not only management and the quality manager. Human side of change processes . as it is a way of registering your quality.4)‘. leading to a continuous improvement for the patients.12. Consider the audience and adjust the content of the presentations to suit them. The standard mentions that ‗Laboratory management shall implement quality indicators for systematically monitoring and evaluating the laboratory‘s contribution to patient care. laboratory management shall address them regardless of where they occur (ISO 15189. 4. decide what needs to be discussed and how the data will be presented. he or she deﬁnes the agenda.
Each individual will go through these phases. be ﬁrm.4 seven elements that influence change readiness Fig. involving the identiﬁcation of different forces together. start exploring them and develop alternatives to go about with the changes. The forces can be prioritized and appropriate actions should be deﬁned to minimize disablers and stimulate enablers so that change becomes possible. They progressively become aware that the change is signiﬁcant and may begin to doubt and become angry. tracking NCs and so on) and when they should be implemented is deﬁnable. do not minimize their efforts and be positive. patiently repeat the message and the facts to people in the ‗shock and denial phase‘. as it is a cyclic process. they may become depressed. as described by Ku¨bler–Ross. can increase the effectiveness and efﬁciency of the change you would like to implement. people tend to deny the impending change and continue with their work. A useful tool to help navigate more efﬁciently through the whole change process is force ﬁeld analysis. Once people accept what is going to happen. skills. but when managed well. during which they receive new information. The underlying concept is that every situation involves a balance between conﬂicting forces. After a period of inner struggle. This resistance cannot be avoided.4 seven elements that influence change readiness . whereas restraining forces (disablers) inhibit you from reaching the goals. If they start to negotiate. The different steps (writing SOPs. together with his staff members.One of the biggest challenges in implementing QS in the laboratory lies in overcoming the natural reluctance of team members and convincing them of the value of QAu to justify the effort that will be required. This linear process is usually organized with the help of techniques such as project management and is restricted in time. procedures. resulting in the need for ﬂexibility. The scientists will go through a learning process. give them the opportunity to blow off some steam and listen.  Initially. Second. Fig. Tension will emerge between those two processes and this will cause resistance during a change process. they accept the situation and plans can be made to continue. Force ﬁeld analysis is usefully carried out as a group exercise. In an attempt to implement change. but at different speeds. This process differs between individuals and cannot be managed in the same linear manner. The cyclic process mentioned above encloses different phases people may go through when confronted with change. In the last phase. For example.4 seven elements that influence change readiness Fig. in particular from the management. driving forces and restraining forces. Driving forces (or enablers) are actions. experience certain emotions try out new things and adapt to and integrate their knowledge. people see new opportunities. which helps to traverse the phases of change in a participative way with your team or department (group problemsolving tool). Consequently. people will negotiate and try to maintain the status quo. to implement QS. which can be followed by encouragement. However. When it is accepted that change is inevitable. the behavioural change – the reaction of Scientists in the laboratory – cannot be planned in time. first. Implementing a speciﬁc change in the laboratory is a linear process. people and other factors that help to move towards the desired objectives. the head of the laboratory decides. equipment.
4 seven elements that influence change readiness CONCLUSION: Recently. the council has opened new positions including that of director accreditation and regulatory affairs this is in addition to its collaboration with the various donor agencies and implementing partners in Nigeria. This will surely assist the laboratories in Nigeria in smoothly scaling through international accreditations. Beyond accreditation is a continuous quality improvement towards a sustainable patient care and safety in Nigeria.Fig. The Medical Laboratory Science Council of Nigeria has a lot to put in place towards local accreditation of laboratories in Nigeria. . The USG laboratory technical working group has been supportive.
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The Twelve Quality System Essentials in Laboratory Certification and Accreditations: .
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