Setting Up a Point-of-Care Testing Service in a Greenfield, Quaternary Hospital: An Implementation Review Open Access

One of the first observations by those initiating this project was that getting things done in the Middle East takes longer. The local attitude to time is flexible. Greater value is placed on relationships developed than on the task itself. An acceptance of this slower pace and factoring that into the project management timeline is an important element for project managers to consider.

The procurement of equipment and delivery of supplies and reagents also takes longer. Because of unique circumstances in the Middle East, it is not always possible to deal directly with vendors. Go-betweens or companies that are registered in the region must be used. Caution is advised when selecting and managing local partners. Business and personal friendships are considered the same in much of the Middle East. People generally prefer to do business with people they know and like, and that is particularly relevant in this region. Small talk is more than just a courtesy, it is a vital means of creating meaningful and tangible relationships. The expertise and technical support that are easily taken for granted do not always exist. Local companies add another layer of bureaucracy when trying to resolve issues and problems. The timely delivery of supplies can not be assumed, and mitigating steps are necessary to ensure critical supplies are always available. Over time and through networking and relationship building, staff can learn how to ensure sufficient supplies are available. Learning to embrace flexibility and patience are important traits because there will be changes in schedules and plans, even at the last minute.

From learned experience, only vendors with proven records of good service and timely deliveries are considered for any POCT instrument procurement. The POCT instrument selection process involves close collaboration with supply and clinical engineering departments to incorporate their input and feedback. This is a key consideration when the POCT committee reviews all options and makes an informed decision.

Effective communication is another important consideration, especially for POCT personnel who are responsible for training staff. The United Arab Emirates is diverse both ethnically and culturally. Most of the workforce comes from South Asia and includes large groups of Indians, Pakistanis, and Filipinos. This ethnic diversity is reflected in the health care system as well. Communications across cultures is a great challenge within the global economy. Established communication methods from home countries need to be honed and improved to work effectively in the United Arab Emirates. This was particularly true for CCAD, an organization that employed staff with more than 90 nationalities. Decoding body language can be as important as the spoken word. These unique challenges are not something that can be handled in advance; they must be accepted and addressed professionally. CCAD addressed this challenge by creating an intensive cultural-awareness programs for all care givers who joined the hospital staff.¹² 

During current training sessions, the POCT department personnel avoid asking questions with yes/no answers. Trainees are asked to reflect on and summarize what they have learned and to communicate that knowledge back to the trainer. A variety of techniques were used to assess a trainee's understanding of each POCT device, including testing that is waived. For example, direct observation is mandatory and so are problem solving skills. Checklists have been created for trainers on the various hospital floors to ensure that content is covered comprehensively and all assessment techniques are used.

An important question to be posed at the outset is how the service will be managed? Point-of-care testing is often a subdiscipline of clinical chemistry. However, POCT incorporates other disciplines such as hematology (including coagulation and platelet function testing), microbiology (for infectious diseases) and molecular biology (such as training in rapid polymerase chain reaction testing). Technologies in these areas involve a variety of different analytic principles: reflectance (eg, urinalyses), lateral flow and electrochemistry (such as glucose, gas, and electrolyte testing), and multiwavelength spectrophotometry (eg, co-oximetry) amongst others.

The primary laboratory at CCAD was divided into 2 sections: a clinical laboratory and an anatomic pathology laboratory. The clinical section was divided into microbiology, blood transfusion, hematology, biochemistry, and specimen reception or referral. Each of those departments was led by a head technologist who was directly answerable to the laboratory manager. The head of each department was a pathologist who reports to the chief of the Pathology & Laboratory Medicine Institute.

CCAD decided that POCT was a unique pathology discipline with its own challenges, accreditation requirements, and regulations; therefore, a separate POCT department led by the POCT medical director, the POCT manager, and dedicated staff was established.^7,13  The POCT technologists report to the POCT manager who reports directly to the technical director. The POCT department works closely with the laboratory quality manager on all quality and accreditation initiatives.

CCAD implemented Clinical and Laboratory Standards Institute guidelines for POCT, with a director being responsible for the overall operation and administration of the POCT program and a POCT manager responsible for technical and scientific oversight, training, and competence assessment of testing personnel. The manager also has a key role in selecting the testing methodologies appropriate for clinical demand and verifying their performance accuracy (Table 1).

The primary responsibility of personnel in the POCT department is to provide adequate support for the end users; to ensure quality testing is performed at the point of care; to provide ongoing evaluations of the equipment, their maintenance, and inventory control; to ensure documentation control; to train and certify users of the equipment; and to conduct audits to ensure compliance with local and international standards and regulations (Figure 1).

When establishing a POCT program, it is important to identify and involve key stakeholders and to initiate a well-defined organizational structure that includes a POCT committee. Membership in that committee should include clinical engineering, hospital risk management, nursing leadership, information technology (IT) staff, clinicians, the POCT manager, pathologists, hospital quality and finance departments, and nursing educators to ensure a multidepartmental approach is adopted^{1,7–11,14–20}  (Figure 2).

Essential documents included the POCT charter and policy guidelines, which were developed by the POCT committee and endorsed by the hospital governing committee.

The charter detailed the committee membership and the rules and procedures on how the committee is to be governed. It also highlights the reporting relationships with other committees at the hospital, particularly the medical executive committee (Figure 3). The strategic role of the POCT committee was described in the POCT committee charter which was signed by the chief executive officer of the hospital (Figure 4).

Developing the POCT policy document, a high-level document outlining the core principles and rules applicable to the discipline, was the first step in clarifying the function of the POCT program. It also defined what POCT is for CCAD. These guidelines provided clarity if questions were raised about certain types of testing or devices. Every hospital has its own definition of POCT, outlining the scope of testing at that institution.^{1,7,9–11,14} 

A POCT service level agreement was created to clearly outline the roles and responsibilities of all those involved with POCT within the organization. Roles and responsibilities for POCT services can be a contentious subject and can occasionally cause friction and misunderstanding between laboratory personnel and clinical staff. Service level agreements are useful for clarifying responsibilities, and they provide additional emphasis when endorsed by hospital leadership.

Details in the service level agreement included equipment ownership and maintenance, result reporting, critical result notification, risk management, regulatory and accreditation compliance, billing, reagents, quality control (QC) processes, advisory services, and training and competency testing. For any test performed both in the laboratory and at the point of care, roles and responsibilities were clearly defined. Some of the tasks in the service level agreement were performed exclusively by the POCT department, whereas other procedures, such as training/recertification, were performed collaboratively with end users.

A critical initial step was to determine the scope of the POCT testing required at CCAD,^2–6  which required a needs assessment determined by direct meetings with various hospital departments to ascertain their requirements. CCAD has 10 major clinical departments (called institutes at CCAD)—(1) neurology, (2) medicine, (3) surgery, (4) cardiac and vascular services, (5) ophthalmology, (6) emergency medicine, (7) digestive diseases, (8) anesthesiology, (9) respiratory and critical care, and (10) imaging—in addition to pathology and laboratory medicine.

The neurology institute runs a stroke program so expeditious prothrombin time and international normalized ratio results were needed.

Cardiac surgeons and cardiac perfusionists also had a list of requirements, as did the anesthesiology institute. The ED staff had their own unique requirements with multiple tests and a turnaround times of 30 minutes required. CCAD decided it was more efficient to open a satellite laboratory in the ED to meet its needs. The POCT staff also equipped an isolation room with various POCT equipment within the ED space to be able to respond to any potential epidemics. At the time of opening, both Ebola virus and respiratory syndrome coronavirus infections were potential threats in the Middle East. A list of the POCT equipment required at the opening of the ED is provided in Table 2.

The POCT committee acted as the gatekeeper for any new technologies and instruments, providing institutional oversight and review of POCT equipment across the facility. Evaluating requests was a major responsibility of the committee (Figure 3). Every new application was judged on its clinical effectiveness, evidence base, and cost effectiveness.^{1,8–11,14–17,19–24} 

The existence of an equivalent test in the main laboratory was a consideration, and if that was available, an investigation was required to determine why that was not adequate. Simple changes to existing laboratory workflows can sometimes negate the need for a POCT solution. The entire clinical pathway was also an important consideration in determining whether real improvements would be made elsewhere, rather than an inappropriate focus on laboratory reporting times. Patient workflows sometimes need optimizing to enhance the effectiveness of the POCT technology.

Local regulations and international accreditation requirements for the POCT set the foundations for the establishment of a POCT quality management system (Figure 5). The Abu Dhabi Department of Health standards for POCT include definitions, clinical governance framework, analytic requirements, staffing and training, performance and quality management, quality outcomes, result interpretation and documentation, safety requirements, and POCT licensing/authorization requirements.⁸ 

CCAD is an extension of the Cleveland Clinic model in the United States. It was, therefore, a natural decision by the Pathology & Laboratory Medicine Institute to apply the College of American Pathologists (CAP) standards to the laboratory. International Organization for Standardization (ISO) 22870 became the international quality and competence standard for the POCT.¹⁴  That standard provides specific requirements applicable to POCT and is intended to be used in conjunction with ISO 15189.^13,15,20,21  The ISO requirements apply when POCT was performed in a hospital or clinic or by a health care organization providing ambulatory care. It was decided that the Pathology & Laboratory Medicine Institute would undergo that assessment as well and become the first hospital to achieve it in the Middle East.

Applying the CAP accreditation requirements for POCT was a challenge because the CAP terminology, definitions, and requirements are different from other regulations and guidelines that many of the staff were accustomed to.^17,18  None of the personnel in the POCT department were Americans or had been exposed to the checklists before, apart from the POCT medical director. The Clinical Laboratory Improvement Amendments of 1988 concept of waived versus nonwaived testing, requirements, and implications, especially in relation to CAP accreditation, was complex and took some time to comprehend.^19,25  It was essential, however, to understand that concept before progressing further. Requirements for waived and nonwaived testing are similar to proficiency testing of procedures, safety issues, result reporting, and reagent handling and storage. Differences exist in calibrations, analytic measurement ranges, lot-to-lot validations, instrument correlations, and methods evaluations. Nonwaived testing requires more-rigorous methods evaluation. For training and competency of POCT personnel, the 6 elements of CAP competency apply to nonwaived testing, whereas waived testing requirements are less onerous.²⁴ 

The checklist approach was intuitive and clear. Laboratory leadership implemented a quality management system and received an early CAP inspection. The CAP accreditation for POCT was achieved 6 months after opening.

The ISO 22870 accreditation was sought from the United Kingdom Accreditation Service because the local agency responsible did not assess that standard. A preinspection or gap analysis was performed in March 2017 with 2 United Kingdom Accreditation Service assessors reviewing our compliance with the management and technical requirements of the standard. A number of nonconformance findings and areas for improvement were identified. After those issues were addressed, a 3-day inspection was performed in late August 2017. The assessment consisted of 3 different tracks: chemistry, hematology (technical), and management. A recommendation for accreditation was made. Accreditation status was granted in February 2018. The granting of ISO 22870 accreditation for the POCT department was a milestone in the development of the service and a testament to all the staff in the hospital and laboratory.

The requirements for ISO are formidable, especially its focus on evaluation and continual improvement. A comprehensive audit program must be in place for all devices, locations, and different staffing types. Audit types included vertical (physician order to final result) witness audits of staff performing POCT, and horizontal or systems audit in which a section of the ISO standard was assessed.

A root cause analysis must be performed for all nonconformances identified. That determination is problematic and difficult when an investigation requires the assistance and cooperation of busy nursing and allied health personnel. Without that collaboration, corrective actions cannot be put into place. The importance of soft skills by the POCT department staff was critical to resolving problems in a mutually agreeable manner. Awareness by end users of the requirements we had to meet for POCT was very helpful and facilitated cooperation. To that end, CCAD made the completion of an online course mandatory during orientation. That course explains how the department is organized and managed, the accreditation and regulatory requirements, and provides instructions on how to report nonconformance or patient safety issues via the online hospital-wide event reporting system.

In our experience, there was some synergy between the CAP and ISO standards. One complements the other in places. The ISO standard tells what the outcome should be but not how to achieve it. The prescriptive nature of the CAP checklist described in detail how compliance could be achieved, which could then be used to meet some of the ISO requirements. The 6 elements of competency, the frequency of assessment, and how they can both be assigned to waived and nonwaived testing was very helpful. Another example of the complementary nature of the standards is where ISO looks for evidence of preventative action under section 4.11. Essentially that determines how future, potential nonconformities can be prevented. The CAP outlines in detail how that requirement can be met through an individualized QC plan.

With ISO there is a particular focus on identification of nonconformance, corrective and preventative action, and continual improvement that is lacking within the CAP checklists. The management component under section 5 is more comprehensive in determining how a POCT service should be organized and managed.

Written procedures reduce variability, and it is that variability in test procedures as well as differing performance ability among operators that leads to errors and discrepancies in results.^{1,7–11,14–16}  Procedures were written according to the ISO 15189 format,^19,20,25,26  which includes the scope (who can perform the test), the principles of the test, the specimen requirements, the reagent/kit storage conditions, the procedure for performing the test, QC, instrument maintenance (if needed), the procedure for performing the test safety precautions, the test result and reporting, the interpretation of test limitations/interferences, and the uncertainty of measurements and calibration. In a startup hospital it was challenging to write all the procedures and ensure they were current and accurate when systems were still in the process of being set up and workflows were not fully established. That problem resulted in multiple published versions of procedures until the workflows were finalized.

Document control also presented difficulties with different versions of a particular procedure across multiple sites within the hospital and became a nearly impossible task to avoid the potential for end users to photocopy uncontrolled versions. The hospital procured an online document management system 1 year after opening. Recognizing the difficulties the POCT department was facing, the hospital quickly opted to use the facility's newly acquired online document management solution, moving away from hard copies.

Selection, installation, and validation of the most-appropriate device are requirements for a successful POCT program.^{1,7,8,14,15,19,22–26}  In the CCAD facility, instruments were procured as part of the hospital building program before key laboratory personnel were hired. The selection criteria that now applies to all new instruments was not applied to some of the initial purchases.^9–11,27,28  Important considerations, such as ease of use, system performance characteristics, software/firmware features, vendor support, delivery time of reagents, and cost were not adequately considered. That resulted in some changes in the POCT scope when the department became operational. All of those important criteria are now part of the procurement process.

The approach to validation requirements for waived versus nonwaived tests involved deliberation between the POCT manager and POCT medical director. CCAD decided that all POCT instruments were diagnostic, and for the verification of test methods, nonwaived criteria would apply to all. Those criteria included validation of the reference range accuracy and precision using Clinical and Laboratory Standards Institute guidelines, calibration, verification/linearity, and method comparison.^{1,5–11,19,21,25,27} 

For ongoing CAP requirements, the application of nonwaived criteria to waived instrumentation was considered unsustainable and waived criteria were applied, with some exceptions. The importance of periodic method and instrument-to-instrument comparisons cannot be overstated. The veracity of POCT results and instrument performance are frequently questioned, and evidence must be readily available to reassure medical and clinical staff. This is ultimately the best method of determining the accuracy of POCT.

When incorporating new POCT into any hospital system, integration and connectivity are crucial and challenging issues; CCAD was no exception. An integrated system allows patient identification electronically, operator traceability, reporting of results to the patient's permanent medical record, real-time device monitoring, and remote maintenance and management.^{1,7,9–11,16,21–23,29} 

The POCT devices may interface directly with a laboratory information system (LIS) or a hospital information system (HIS), but because of costs associated with interfacing multiple devices, many POCT programs look to use a connectivity platform, often referred to as middleware. Middleware allows connectivity among multiple POCT devices by various manufacturers within a single interface connection through either the LIS or an HIS, depending on the hospital's reporting policy. At CCAD, all POCT devices were routed through the LIS rather than directly into the HIS, which added further complexities and issues. Through optimization of services in the future, CCAD will consider routing the middleware directly through the HIS.

When choosing a middleware vendor, it is important to consider the system's ability to connect with various devices and to determine whether use of a system provided by a different vendor will jeopardize any functionality that is crucial to the operations of the instrument and the POCT personnel. When purchasing new devices, it is imperative to consider IT connection options and to evaluate the features of the device thoroughly.

At CCAD, middleware was not procured at the outset for some critical POCT instrumentation, which meant that various alternative reporting systems had to be established to ensure result entry into the electronic medical record. At CCAD, these alternative reporting systems were directly interfaced between the equipment and the LIS. Creating interfaces between POCT software or devices with the LIS/HIS is expensive, and the time required for the approval process can be lengthy. Competing demands by the IT department in a laboratory and hospital in startup mode meant that POCT IT projects were not initiated immediately but were processed according to priority.

Use of laboratory IT systems by hospital staff posed challenges because they were unfamiliar with the key steps in data entry that are typically performed by laboratory technologists, which includes receiving specimens and reporting results.

Vendor-neutral middleware has now been procured for CCAD, which will enable rapid and easy performance of tests for the busy clinical staff bypassing conventional laboratory-reporting workflows. The vendor-neutral purchase which can interface with a long list of instruments, ensures more choices when instrument selections are being considered as opposed to vendor-specific options with limited capability for other suppliers' instruments.

Positive patient identification was another challenge. With the speed of result entries that middleware offers, the misidentification of a patient can have serious consequences. The use of patient wristbands was a discussion that POCT initiated with interested parties at the outset. Inpatient wristbands are taken for granted but outpatient clinics for example, where wristbands are not typically used, must also be considered. It was difficult to provide positive patient identification in a setting in which patient names are often similar and the date of birth does not offer a unique identifier. The United Arab Emirates was founded in 1971 with no formal birth registry existing before then. Frequently, the date of birth is listed as January 1 of the year in which a patient was born. For patient safety all patients in CCAD are given barcoded wristbands including patients attending outpatient clinics. This may be considered an expensive solution but from a patient safety perspective, it was deemed to be absolutely necessary. Troubleshooting was needed to identify a correct barcode type that all POCT instruments would recognize for identification of both the patient and the operator. After a few weeks of investigation, a compatible barcode type was identified.

The POCT results must be documented in a patient's electronic medical record. Data included in the record must incorporate the units of measure, the specimen type, the critical values, and the reference ranges pertinent to the local population. Traceability to the performing operator and a clear demarcation of POCT results from the central laboratory are also important considerations. Moreover, POCT technology is frequently used for screening and monitoring rather than solely for diagnostic purposes, so it is important that results be clearly identified as such. The specimen type is usually whole blood and this has its own distinctive limitations. It is important that confusion with the methods used in the main laboratory be avoided.

This facility's POCT policy requires result entry to be performed by electronic transfer wherever possible rather than by paper charting. Manual entry of results increases the possibility of transcription errors and a lack of consistency in how the data are entered.

Most errors relating to POCT are not usually related to the analytic performance of the instrument but occur during the preanalytic phase, that is, they are associated with the operator.^* Such errors result from inadequate training, miscommunication, and misunderstanding. An effective well-structured and standardized training and competency program is vital to ensure quality and patient safety. CCAD met the documentary requirements by using a hybrid of hospital-produced materials and those provided by vendors. Materials produced included quizzes, observations, record reviews, demonstrations, and troubleshooting. The CAP stipulates that for waived testing, training and competency are performed when a staff member is introduced and competency is reassessed annually thereafter.^9,10  For nonwaived testing competency is assessed at introduction and reassessed at 6 and 12 months and once a year thereafter. For nonwaived testing, the 6 elements of competency, per CAP, must be assessed. Those elements include direct observations; maintenance and test performance; monitoring of test results; review of QC, proficiency testing, and maintenance; running specimens with unknown values to the end user; and troubleshooting, among others.

Simultaneously initiating caregivers from all departments in the hospital on a piece of laboratory equipment posed difficulties. Many staff members required training on a wide variety of POCT instrument technologies, which was a significant administrative and logistical exercise. Accommodating the variety of staff and the different mind sets, skill sets, and experiences of each staff member was a challenge. The volume of caregivers who required training exceeded the capability of the POCT department personnel, particularly for glucose POCT. Support existed at the highest level of the nursing administration who provided education and training to assist in completing the task. Having that kind of multidisciplinary support and collaboration was important in successfully training several hundred nurses in a short time. Laboratory and nursing leadership must have a mutual understanding and appreciation of one another's departmental operations and requirements, so they can support each other in their respective service deliveries to the patients. Such a collaborative approach continues with nursing education at CCAD today. Achieving recertification requirements without such cooperation is impossible.

With hundreds of staff needing training for a core competency such as glucose testing, training documentation posed another challenge. A paper-based system detailing all the concomitant requirements such as patient sampling, QC, and exams, posed significant administrative demands. The management of all those requirements over time with more than 1000 staff members, and contending with perennial recertification, ensured that discussions took place quickly about procuring software that would connect the instruments and allow initial and subsequent certifications be performed and recorded electronically. That autocertification system for glucometer and coagulation instruments was installed and tested before the hospital opened, which ensured that CCAD was able to provide all training and competency requirements for those devices more efficiently (Figure 6).

Responsibility for glucose POCT training at new caregiver orientation was ultimately assumed by nursing educators in a bilateral arrangement. The POCT department performs all the administrative responsibilities associated with that task, such as setting up rooms for training with instruments, documentation, training and reading materials, and setting up the operator identification on middleware, among other tasks.

Tracking and monitoring of competency records for all other devices is performed manually which is very challenging, particularly when competency periods expire. Paperwork is kept centrally and all details recorded and tracked on a spreadsheet. More software has now been procured and CCAD intends to implement a similar autocertification system for all devices.

The quality of the training given by POCT instructors is paramount. The POCT department evaluates that periodically by performing surveys either by POCT staff or by hospital-based educators who have been identified by the department as suitable of those who have completed POCT training. Suggestions and feedback are considered by the POCT department, with changes and improvements occurring periodically.

One of the most challenging aspects of introducing any quality management system is establishing an effective system of identifying, reporting, and managing nonconformities and an end-user awareness of the POCT accreditation requirements.^† Developing that system can be very challenging when there are hundreds of devices and operators. The POCT department at CCAD created a mandatory learning module in conjunction with the education department to address those needs. That quality module covers all major elements of clinical governance and international accreditation including local regulations. It also satisfies the ISO requirements that service staff be familiar with and understand the institution's quality management system.

CCAD uses an online incident reporting and risk-management system. Intuitive software with different icons directs hospital staff to the appropriate drop-down menu with specific fields in which to record event information. Instructions on how to report any event are included in the quality module. Meetings were held with the hospital quality and risk department to identify solutions that facilitate effective management of POCT nonconformities. As part of that hospital-wide event reporting system, a specific POCT option was created as part of the menu to allow hospital staff to report events more accurately.

The POCT department also has its own internal event reporting system, which is part of the quality department system in the laboratory. Currently that system generates the bulk of nonconformance data for the department. The system is manual using spreadsheets. A nonconformance form is used whenever any nonconformance is identified. The data from those forms feeds into the POCT customized spreadsheet which provides meaningful data by location, caregiver type, instrument type, and testing phase (preexamination, examination, postexamination). The POCT department is currently working with nursing-quality staff to establish the most effective way to deal with the most common errors identified. The ISO 9000 standard defines audits as the “systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.”³⁴  There are 3 types of internal audits performed at CCAD: vertical, horizontal, and witness or examination audits (Table 3). The objective of audits is to identify nonconformities and to address them. The POCT department also wants to identify potential nonconformities, that is, situations that may cause future issues. Nonconformities are documented within 30 working days of the event. The POCT department addresses the ISO 15189 auditing requirements by maintaining an audit schedule with a cycle that is completed annually.

The POCT department at CCAD continually strives to improve its service to the end users; therefore, a POCT email address was created to allow the end users an easier and more convenient method of communicating with the team. The department also periodically seeks input from hospital staff about how POCT services and training can be improved. For example, suggestions from our nursing educators and POCT users have led to simpler and shorter knowledge tests for glucose POCT. We also have suggestion boxes throughout the hospital that generate regular feedback.

Point-of-care testing is a unique pathology discipline. The successful performance of relatively simple tests cannot be taken for granted by caregivers who are clinically focused on patients, rather than on the technical performance of the POCT equipment or the limitations of a particular sample type. The challenges in the setup of a POCT service in a greenfield hospital are many and varied and include ensuring the right equipment is obtained through a rigorous selection criteria process and the setup of a dedicated POCT department with adequate resources.^{1,8–10,14,22} 

Institutional oversight is best achieved through the establishment of a POCT committee with a multidisciplinary membership and support to ensure effective clinical governance.¹⁵  Ensuring a robust quality assurance system is established, with regular reviews of internal QC and participation in an external QC program, is crucial.^1,9,10,16 

Data and instrument management software for all POCT devices is not only preferable but vital to ensuring appropriate support for end users and to improving patient safety because of the ability to constantly monitor instruments, users, and results.^1,22,29 

Initial and ongoing training and competency of POCT personnel is a continual task.^1,8,14,25,26  Remote management of those functions is preferable to assist in compliance particularly in large organizations. Effective risk-management processes are needed to mitigate harm and minimize system failures.¹⁷ 

For patient safety, all POCT results must be recorded in the electronic medical record system in a timely manner. Electronic transfer of data is preferable to assist in timely result reporting and to reduce transcription errors as well as to ensure ongoing compliance for recording of units of measure, reference ranges, critical values, and operator identifications, among other parameters. Finally, accreditation of the service to international standards ensures the highest standards are met with independent assessment to ensure patient safety.