Ensuring Quality Healthcare: The Evolution and Impact of US Laboratory Regulations - Paper Example

Introduction

The United States (US) laboratory regulations have a transitory past ranging from 1967 to 1988. In 1967, federal agencies obligated their clinical laboratories to comply with quality standards consolidated within their legislations. The regulations fell under the 1967 Clinical Laboratory Improvement Act (CLIA). The objective of these regulations was to enhance the quality of diagnostic tests for patients. However, in the 1980s, interested parties call attention to errors in some testing procedures. In an attempt to resolve the inaccuracies, the US federal agencies enacted the 1988 CLIA.

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The 1988 Clinical Laboratory Improvement Amendments are regulatory standards for monitoring and assuring quality clinical laboratory testing (Anderson 184). The CLIA governs the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA). Each of these federal agencies has a definite role in ensuring the quality of laboratory testing. CLIA's objective is to guarantee the worth of laboratory testing and ensure compliance with all medical protocols and policies.

Medical diagnostic examinations aid the medics and lab technicians in identifying specific diseases and monitoring their health. Besides, diagnostic tests assist healthcare providers in decision-making regarding the patient's care. Therefore, CLIA plays a crucial and significant role in upholding the healthcare sector's quality and integrity. Nonetheless, the efforts of CLIA may be ineffective in the absence of CLIAC.

Davey et al. point out that the 1988 CLIA regulations consist of countless provisions highlighting managing patients' tests, classification of medical texts, and medical team standards (2). Following the enactment of the CLIA standards, accreditation institutes remodeled their inspection operations. The modifications included the enhancement of inspector training and the frequency of laboratory inspections. Since its inception and implementation, the CLIA has had additional improvements to address emerging medical issues of laboratory testing and practices. The reenactment of CLIA was to fill the gap of having well-trained, dependable, and efficient inspectors (Davey et al. 4).

The Role of CLIAC in Clinical Laboratory

A Clinical Laboratory Improvement Advisory Committee (CLIAC) was put in place to safeguard the goals and objectives of CLIA. The CLIAC's role is to advise and make recommendations on the scientific and technical issues surrounding the CLIA regulatory framework (Davey et al. 6). The committee's considerations are towards addressing all the laboratory facets, such as cytology, pathology, and medicine.

The CLIAC shall provide guidance and advice concerning technological advancements, research studies on health safety improvement, and laboratory practices' effectiveness and efficiency. However, CLIAC does not make or approve any legislation but plays a purely advisory role to government agencies. The federal bodies rely on CLIA to establish their respective legal framework.

According to Anderson and Stang, laboratory testing plays a significant part in detecting and spotting microorganisms causing infectious diseases and evaluating diagnostic health conditions (183). The CLIA framework ensures that the laboratory tests are up to the standard requirements of the medical sector. Consequently, the confidence and trust of the patients regarding their laboratory tests increases. Ehrmeyer and Laessig claim that Proficiency Testing is the only objective measurement of the quality of the 1988 CLIA (38).

On the other hand, lab technicians can rely on a patient's data from a colleague in a different federal area. Since its formation, the CLIA has ascertained that uniform quality standards apply to all people regardless of their geographical location (Anderson and Stang 184). The move to standardize the quality of laboratory and diagnostic tests has to be an achievement in medical practice. CLIA is an official mechanism for federal agencies that communicate on issues affecting laboratory medicine and diagnostic tests. CLIA provides a channel through which medical professionals can address and recommend issues that may require regulations.

Davey et al. argue that because of CLIA regulations' flexibility, the laboratory processes and cytology quality have improved and given room for the development of technological advancements in the medical sector (8). Clinal laboratory tests are significant in the CLIA framework. According to CLIA, a clinical laboratory is any facility offering laboratory testing services on human specimens to give diagnostic information to prevent and treat disease. In these labs, the role of CLIA is to ensure that they deliver safety, accuracy, and efficiency.

Requirements of the CLIA

To ensure compliance and prove that the clinical labs have met the standards, the CLIA provides them with particular requirements. One of the CLIA requirements is the Quality Control and Assurance (Ehrmeyer, 28). The testing facilities must create effective quality control (QC) measures and practices. The labs must implement strict QC protocols to examine their instruments' performance and the effectiveness of procedures. These QC protocols are for waived testing. Also, under the QC requirement, clinical Unders must stipulate a formal list of policies and guidelines for all their operations and corrective measures in the event of errors (Ehrmeyer, 28). Another QC requirement is appropriate communication between patients and the personnel and proper record-keeping and documentation. CLIA provides effective and suitable communication protocols for safeguarding the privacy and confidentiality of patients' data. Another CLIA requirement for clinical laboratories is a procedural manual.

A procedural manual is a document that should be available on the lab premises always. This manual provides a chronological of all operations within a lab. Such procedures include equipment and machine calibration, lab testing, employee training, staff performance appraisal, and reporting of patients' test results. Personnel training is vital in ensuring that the medical sector consists of qualified, competent, and effective healthcare providers (Davey et al. 6).

Besides, to gain the approval of CLIA, clinical laboratories must meet the requirement of ensuring that they hire the best employees. On the other hand, there is a direct relationship between having competent workers and providing quality and reliable laboratory tests and health care.

The Impact of CLIA

Anderson et al. claim that since CLIA gave CLIAC the mandate to advise it on its undertaking, there has been input on better laboratory practices (129). Anderson et al. accredit the medical arena's improvements to CLIA's establishment of universal quality standards for all laboratory testing. Regardless of where the patient received the test, CLIA has managed to make laboratories deliver accurate, reliable, and timely results. Ehrmeyer and Laessig argue that by integrating a total quality management-based approach, laboratory managers warrant quality clinical practices (37). Therefore, CLIA has managed to control and bring a commitment to adhering to health standards and protocols.

Another impact of the 1988 CLIA is that the regulation has enlarged federal oversight of nearly all US clinical laboratories. CMS data on CLIA shows that the implementation of CLIA and its recommendations has led to improved quality of testing in the US. CLIA has had a critical effect on access to laboratory testing services. According to Born and Thran's study, more than half of physicians send their patients to external testing facilities (319). However, there is a negative impact and inconvenience for patients by failing to undertake laboratory tests in-house. There are time-wastages and delays in giving the test results. Besides, the halts the reliability and quality of the tests.

CLIA ensures that specific and uniform medical protocols and guidelines are available in most, if not all, of the clinical laboratories in the US. Health care relies on the CLIA regulations because disease treatment commences on diagnostic tests. Also, the health and wellness of patients has become a priority. The reliability, accuracy, and timeliness of laboratory testing ensure that the public is confident about the kind of treatment they receive. Besides, the CLIA framework incorporates dispute mechanisms that lab technicians and patients can use in the event of a misunderstanding. As stipulated in the CLIA regulations, the procedural manual plays a critical role in ensuring that every physician follows and can refer to a uniform reference tool.

Conclusion

The CLIA laboratory testing regulations have improved the collaboration of government agencies and medical stakeholders in ensuring the quality provision of health care. The CLIA regulations not only ascertain quality control measures but also recommend qualified personnel to execute the recommendations. Therefore, CLIA plays a significant and vital role in the quality of laboratory testing.

Works Cited

Anderson, Nancy. “Promoting Good Laboratory Practices for Waived Infectious Disease and Provider-Performed Microscopy Testing.” Clinical Microbiology Newsletter, vol. 39, no. 23. Dec 2017, pp. 183-189.

Anderson, Nancy, et al. “The Impact of Clinical Laboratory Improvement Advisory Committee Recommendations on Microbiology Laboratories.” Clinical Microbiology Newsletter, vol. 31, no. 17. Sept. 20009, pp. 129-137.

Born, Patricia, and Thran, Sarah L. “The Influence of CLIA ’88 on Physician Office Laboratories.” The Journal of Family Practice, vol. 46, no. 4, April 1998.

“Clinical Laboratory Improvement Amendments (CLIA)”. U.S Food & Drug Administration (FDA). https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia Accessed 6 Oct. 2020.

Davey, Diane Davis, et al. “The Impact of the Clinical Laboratory Improvement Amendments of 1988 on Cytopathology Practice: A 25th Anniversary Review.” Journal of the American Society of Cytopathology, April 2014, pp. 1-11.

Ehrmeyer, Sharon S. “Satisfying Regulatory and Accreditation Requirements for Quality Control.” https://sci-hub.do/https://doi.org/10.1016/j.cll.2012.11.007. Accessed 7 Oct. 2020.

Ehrmeyer, Sharon S., and Laessig, Ronald H. “Has Compliance with CLIA Requirements Really Improved Quality in US Clinical Laboratories.” Clinica Chimica Acta 346, Dec. 2004, pp. 37-43.