Plan For Quality to Improve Patient Safety at the Point of Care

Introduction

In medical practice, patient care is of paramount importance. There are several cases of adverse care healthcare events that affect patients on daily basis (Downer 2003). In 2000, the U.S. Institute of Medicine reported that over 98,000 patients in America succumb to medical error related complications. This report alerted the public and the medical community and focused attention on ways to improve quality and eliminate medical errors to ensure patient safety. In spite of efforts to do away with these errors, errors are still widespread. More recent studies report that as much as 45 percent of every dollar spent on U.S. health care, is related to medical mistakes and that some of these errors are prevalent in a third of hospitals. The key phrases in these reports are “mistakes” and “preventable medical errors,” which means solutions can be found and implemented. (Ehrmeyer, Sharon, Laessig & Ronald, 2007). This paper seeks to assess patient safety at the point of care. Of particular interest are the errors that arise during point of care procedures, the safety measures that are in place and the various ways through which patient safety is being improved.

Patient safety areas of concern at the point of care

The healthcare system is designed to ensure the safety of patients. Many development have been carried out to assure the safety of the patients in variety if clinical situations including the point of care. The procedures carried out at the point of care, mainly point of care testing (POCT) have been optimized to ensure maximum patient safety. However, there are still many cases of errors arising at the point of care which risk the safety of the patients.

There are many instances in which patient safety is compromised at the point of care. In fact, the WHO refers to patient safety as an endemic concern (Downer, 2003). Circumstances that might compromise the safety of the patients at the pint of care can be categorized broadly into Human factors, Medical complexity, and system failures. Human factors often relate to the variations in the training and experience of the healthcare provider, depression, diverse patients and unfamiliar settings (Kost, 2003).

Medical errors that can compromise patient safety at the point of care may arise due to complicated technologies, powerful drugs and prolonged hospital stay (Plebani, 2010).

Patient safety can also be compromised by a number of errors that may arise due to system failures. These errors are common and may include: Lack of communication and unclear chain of command; a high patient to nurse ratio; the impression that the patient is being taken care of by another person; confusing names of drugs and reagents that may look alike; a disconnected or useless hospital reporting system.

Point-of-care testing (POCT)

It’s important to note that most errors related to point of care occur due to point of care testing (POCT). By definition POCT relates to; any testing that is conducted outside the central clinical laboratory and near the patient. The popularity of POCT keeps increasing and is based on the assumption that; test results available in a remarkably short timeframe assist caregivers with immediate diagnosis and/or clinical intervention to benefit patient outcomes. Patient safety, in the context of the POCT process, is freedom from unintentional or preventable harm due to avoidable adverse events (medical errors) that directly affect the quality of the test result and ultimately the quality of care (Kohn et al., 2000). Errors can occur anywhere in the entire POCT process, from deciding to order a test (pre-pre-analytical), to ordering and collecting a patient sample, through the analytical process, to reporting and finally acting appropriately on the result (post-post-analytical). Patient safety potentially can be compromised whenever there is a disruption in achieving all of the necessary “correct” quality criteria throughout the process, i.e. correct test order, correct patient, and correct specimen collected at the correct time, correct test result, correct patient record, and correct clinical interpretation leading to the correct and timely clinical response (Kohn et al., 2000).

Plebani et al and others described the frequency of errors in the three phases of the total testing process. The most cited POCT deficiencies impacting the analytical phase include; failure to perform and document quality control, follow the procedure and manufacturers’ directions, perform and document personnel training and ongoing competency, take appropriate corrective actions, verify accuracy of analytes tested, and document results in the patient record (Plebani, 1997, p. 1348). Meier and Jones, in their seminal papers, identified three basic sources of POCT; error-operator incompetence, not following protocols and uncontrolled reagents and equipment, also suggested that wherever POCT errors occur, the effects of these errors are amplified by incoherent or no regulation, the availability of rapid test results often reported without appropriate quality checks, and immediate therapeutic decisions and treatment based on these rapid results. “Amplifiers” as used by these authors are factors, which increase both the frequency and magnitude of the errors. Numerous articles that include extensive references enumerate examples of POCT errors (Downer, 2005, p. 1).

POCT is an ever increasing and significant component of hospital services and just like the central laboratory, POCT requires strategic planning, management and leadership. This approach not only provides clear lines of responsibility, authority, professional expertise, oversight, and accountability for the entire process, but also as importantly, addresses error reduction to ensure patient safety. While the exact structure varies with the situation, typically a POCT committee having a common vision to serve best patient needs and meet institutional goals addresses POCT throughout the organization. A primary reason for unsuccessful POCT programs, including sub-optimal clinician utilization patterns, is a failure of the organization to take ownership of the process and involve stakeholders in the decisions for implementation and ongoing activities.

Stakeholders, beginning with hospital administration, come from all areas impacted by POCT. These stakeholders form the nucleus of the “POCT committee or team” and provide the broad-based input that is essential for creating a successful program. By shifting the focus to the institution’s goals, the needs and various viewpoints of physicians and healthcare professionals and the demand for quality, medical error reduction and improved patient safety can be addressed and mostly accommodated (Carraro & Plebani, 2007). A key player in carrying out the directives of the team and ensuring that POCT is conducted in a quality way is the coordinator. Selecting the right one is essential, since the extremely visible coordinator carries out the directives of the committee and is the POCT champion, promoter, helper, resource, rule enforcer, trouble-shooter, and spokesperson.

The importance of the POCT committee and coordinator is reinforced in the International Organization for Standardization (ISO) POCT document. The ISO organization describes itself as the world’s largest developer and publisher of international technical standards on many topics including medical laboratory testing and POCT (Carraro & Plebani, 2007, p. 1338).

Requirements for quality and competence, gives specific requirements applicably to POCT carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. The introduction of this document includes the following statement: “risks to the facility and patient can be controlled using a system that is well-designed and fully implemented and it requires that responsibilities are well defined and communicated by the management”(Carraro & Plebani, 2007, p. 1339). The standard goes on to delineate the requirements through all phases of testing that must be addressed including personnel training and competency. It also specifies the appointment of a person, the “coordinator,” responsible for POCT quality. The approach that ISO specifies to achieve quality at POCT is highly prescriptive and proactive and differs markedly from the regulatory approach of the U.S. government that is disseminated in the Clinical Laboratory Improvement Amendments (CLIA). CLIA stipulates that for methodologies classified as CLIA-waived (now over 100 analytes performed by over 1000 methodologies) and mostly performed at POC, the test site only needs to follow the manufacturers’ directions. This explains the “incoherent or no regulation” amplifier described by Meier and Jones (Meier, 2004).

Improving patient care at the point of care through POCT optimization

The above analysis has determined that most point of care issues that compromise patient safety are related to POCT. It’s therefore imperative that in order to improve patient safety at the point of care then measures that optimize or improve POCT procedures should be adopted.

The primary purpose of POCT is to have results quickly available to the clinician for immediate intervention. While the emphasis on immediate availability of test data is undoubtedly a positive for most applications, it is a negative when the result is incorrect! Instrument selection must take into account the analyst, who often has less insight and knowledge of the testing process. While there are many manual and automated methods available for POCT, not all methods meet the needs of the test site and its clientele and not all are equal in terms of accuracy, precision, and reliability. It certainly is imperative that the coordinator or designee of the POCT committee have input into the evaluation and selection of methods to ensure that testing needs can be met (Meier, 2004, p. 997).

As the evolution continues, technology will move well beyond just automating the many steps of the testing process to autonomation. Autonomation is a process where human intelligence is bestowed on to a machine. The concept encompasses the two pillars of Toyota production: “Jidoka” and “Poka-Yoke,” which translate loosely as “automation” and “mistake proofing” (Meier, 2004, p. 997).

. The concept incorporates the Deming view that correction of mistakes must be undertaken as they occur rather than waiting to take necessary action much later. While, more sophisticated technology is being introduced, the ultimate evolution will be the development of technology that controls and ensures the quality of the entire testing process with minimal operator intervention (Jones & Meier, 2005, p. 1262).

Another essential component of POCT is “connectivity”. Until recently, a lot of POCT data were simply “lost,” potentially impacting the quality of patient care. Fortunately more and more of today’s test devices have connectivity capabilities to capture data in the patients’ records and facilitate better management of the entire POCT process. Autonomation and connectivity will continue to be driving forces in ensuring POCT quality and patient safety.

Train and Check Ongoing Competency

An accurate and precise result that meets the many testing requirements is unlikely to be obtained without a well-trained, competent operator. All those involved in POCT know that a serious challenge concerns the training and ongoing competency assessments of many healthcare practitioner analysts, who have a patient care focus as their primary responsibility. The increased demand for POCT that includes an extensive test menu offered 24 hours a day; 7 days a week complicates training and competency assessment. Of course, all POCT must be in full compliance with a complex set of extremely technical regulations and overarching professional standards usually written with the centralized laboratory in mind (Lewandrowski & Anand, 2005).

Who does the training is exceedingly situational specific and ranges from manufacturers for specific method/instrument instructions to key trainers to laboratory staff. A successful training program incorporates materials that are most recent, easy to understand and address all the necessary components outside the actual testing, such as – institutional policies and procedures, patient identification, patient preparation, sample collection, alert value protocol, blood-borne pathogen safety precautions, and documenting results (Plebani, 2010). Face-to-face instruction by instructors with the same background as the trainee (e.g., nurses training nurses) often is considered to be the most effective approach, however; this may not be possible or practical with large numbers of analysts and/or many geographically separated POCT sites. E-learning packages developed by manufacturers, professional trainers, and/or institutional staff are becoming widely used. Whatever the approach taken, some type of assessment as to the analyst’s competency must be carried out before actual testing is allowed. Training is not a onetime activity. It needs to be undertaken with the ongoing changes in testing protocols and applicable policies and procedures (Plebani, 2010, p. 101).

Once trained, analysts must continue to maintain their competence to provide quality results necessary for high quality care. In the US, CLIA now mandates, at a minimum, an annual competency assessment of authorized testing personnel that include all of the following:(1) Directly observing routine test performance, including patient preparation, if applicable, handling the specimen, processing it and testing it,

1. Checking on the recording, as well as, reporting of test results;
2. Reviewing, if applicable, all intermediate results from the test, or worksheets, records from quality control, testing results involving proficiency, and preventive maintenance records;
3. Directly observing performance of instrument maintenance and function checks;
4. Assessing test performance through testing previously analyzed, internal “blind” orexternal proficiency testing samples; and
5. Assessing problem solving skills(Downer, 2003).

Considering the amount of time, energy, and costs associated with training and competency assessment activities, the POCT coordinator/committee should consider limiting the number of analysts, when possible, and encouraging those people that have a problem following orders/or test infrequently” not to be involved. It is extraordinarily difficult, for analysts performing few tests to maintain competence (Ehrmeyer et al, 2007, p. 766).

Other Strategies to improve overall patient safety at the point of care

1. Healthcare information technology– The adoption of new information technology systems is fronted as one of the mechanisms through which adverse health events can be reduced (Carraro & Plebani 2007). There are suggested computer and internet support systems that are aimed at supplying patient records and providing support clinical decisions. This will do away errors that arise due to wrong clinical decisions and poor legibility of manual records. There are several technologies that will also do away with errors that arise during prescription.
2. Evidence based medicine– Evidence based medicine often integrates the examination and diagnosis of a particular patient’s case with evidence from medical research (Plebani, 2010). The “clinician often utilizes relevant clinical research on the accuracy of the diagnostic tests and the efficacy and the safety of therapy” (Downer, 2003, p. 34). There should be acceleration in the adoption of evidence based practice to improve the overall patient safety at the point of care (Kost, 2003). The benefits of evidence based medicine at the point of care may come in terms reduction in the incidences of adverse events especially those related to diagnosis and medication; provision of standard plans for all specialists attending to patients and adoption of a common framework to improve communication at the point of care setting (Downer, 2003).

Conclusion

This paper sought to assess patient safety at the point of care. Of particular interest were the errors that arise during point of care procedures, the safety measures that take place and further identify the various ways through which patient safety can be improved at the point of care.

The paper has established that patient safety at the point of care mainly arise due human, medical and system errors. The highest percentage of errors is observed during POCT procedures.

Point of care testing (POCT) is regarded as; test conducted outside the central clinical laboratory and near the patient. Errors can occur anywhere in the entire POCT process, from deciding to order a test (pre-pre-analytical), to ordering and collecting a patient sample, through the analytical process, to reporting and finally acting appropriately on the result (post-post-analytical). Patient safety potentially can be compromised whenever there is a disruption in achieving all of the necessary “correct” quality criteria throughout the process-correct test order, correct patient, and correct specimen collected at the correct time, correct test result, correct patient record, and correct clinical interpretation leading to the correct and timely clinical response (Kohn et al., 2000).

POCT will continue to grow and be an indispensable segment of the modern clinical laboratory testing market. For POCT to benefit patient outcomes there is no guarantee that quality testing is automatic. Quality testing and ultimately patient safety demand planning, oversight and leadership provided by the POCT committee and coordinator. Many experts in POCT have given valuable advice and tips to achieve excellence in POCT. However, in evaluating and improving POCT, the total testing process- pre- analytical phase through post-post analytical- must be considered. Even the best test systems, analysts, and testing policies and procedures will be ineffective if the clinicians do not take appropriate advantage of POCT (Ehrmeyer & Laessig, 2007, p. 47).

This paper has also recommended other mechanisms that should be adopted to improve patient safety at the point of care. These mechanisms include adoption of technologies that will significantly reduce medical errors that arise due to illegibility of manual records and prescriptions, and the use of evidence based medicine to standardize operations with evidence base on research so as to achieve an overall improvement in patient safety.

References

Carraro, P., & Plebani, M. (2007). Errors in a stat laboratory: types and frequencies 10 years later. Clinical Chemistry, 53 (7), 1338-1342.

Downer, K. (2005). Five Years After “To Err is Human.” Clinical Lab News, 31, 1-2.

Ehrmeyer, S. S., Sharon, S., Laessig, & Ronald H. (2007). Ehrmeyer, S. S. (2007). Point-of-care testing, medical error and patient safety: a 2007 assessment. Clinical Chemistry Lab Med, 45(6), 766-773.

Jones, B. A., & Meier, F. A. (2005). Point-of-care testing error: sources and amplifiers, taxonomy, prevention strategies, and detection monitors. Archives of Pathology & Laboratory Medicine 129 (10), 1262-1267.

Kohn, L.T., Corrigan, J.M., Donaldson, M.S., Committee on Quality of Health Care in America, & Institute of Medicine. (2000). To err is Human: Building a Safer Health system. Washington, DC: National Academy Press

Kost, J.G. (2003). Preventing problems, medical errors, and biohazards in point-of-care testing: using complex adaptive systems to improve outcomes. The Journal of Near-Patient Testing & Technology 2 (2), 78-88.

Lewandrowski, K., & Anand, D. (2005). Improving point-of-care testing with automated identification technologies. Journal of Near-Patient Testing & Technology 4 (2), 86-89.

Meier, F. A. (2004). Patient safety in point-of-care testing. Clinics in Lab Medicine, 24 (4), 997-1022.

Plebani, M. (1997). Mistakes in a stat laboratory: types and frequency. Clinical Chemistry, 43 (8), 1348-1351.

Plebani, M. (2010). The detection and prevention of errors in laboratory medicine. Annals of Clinical Biochemistry, 47 (2), 101-110.

Appendix

Revision Summary

The paper was revised in the following areas:

• The thesis statement was broadened to capture all the factors that may compromise patient safety at the point of care.
• A section was included in the paper to discuss patient safety at the point of care.
• The paper was also refocused to capture the current technologies and strategies employed in point of care testing and also identify the future action plans that can improve POCT.
• The paper included other strategies that can be employed to enhance patient safety at the point of care. Such strategies include health information technology and evidence based medicine.

New information was sought for in reputable journal databases to make the above changes.