Question

Related to Point of care testing: an excellent policy is written in format that includes purpose of the policy and appropriate sections for the outside department responsibility and the laboratory responsibility and monitoring.

Answer 1

Implementation of a structured Point of Care Test (POCT) program is challenging. Traditionally POCT was unregulated and the aim was to introduce a structured POCT program at our tertiary care hospital to ensure compliance with regulatory standards. The purpose of this article is to describe how a hospital in a developing country with limited resources has approached POCT program initiative. The benefits offered by such systems, including cost-effectiveness, robustness and the ability to generate reliable accurate POCT results in a short time, are appropriate to the clinical and social needs of the developing world

NEEDS ASSESSMENT FOR POCT PROGRAM

Delineating program proposal

Like all laboratory testing, many regulatory guidelines have been put forth to address quality control, training and documentation to ensure patient safety. To start off with a thorough review of literature including International Organization for Standardization (ISO) guidelines, CLSI, Joint Commission International (JCI) and CAP standards specific for POCT was completed by the Chemical Pathologists . A proposal delineating the scope of services was developed at the Section of Chemical Pathology, in the Department of Pathology and Laboratory Medicine, AKUH. It was decided that POCT would be performed in inpatient locations including wards, emergency department, operating rooms, special care units and intensive care units of the hospital. The POCT proposal highlighted the shortcomings of existing bedside testing identified in need assessment.

The core of the document was a regulatory proposal for the implementation of POCT including aspects related to personnel responsibilities, quality assurance, data management, and future tendencies. The goals of implementing the POCT program in the institute were clearly defined in the proposal.

The goals of POCT program were defined as follows:

To ensure that POCT is high quality and cost-effective.

To give guidance to all users and potential users of POCT.

To provide consistency of test offering at all POCT sites.

To simplify billing procedures on POCT sites.

To provide faster turnaround times in test results with minimal inconvenience to the patient.

To provide an organization-wide standardized policy for POCT application.

This document included following initial tasks as part of POCT program: outlining an organizational structure, defining roles and responsibilities of POCT teams and members and describing clinical needs of proposed POCT tests. The proposal was shared and approved by the senior management of the hospital and all stake holdersEvidence based approach for POCT program development

Clinical needs assessment is a process by which information is gathered regarding the scope and potential impact of gaps or deficiencies in the current delivery and practice of health care (18). The POCT need assessment was done to gather information regarding current practices and clinical needs for developing a POCT program in our institute. Multiple surveys and site visits were conducted by the laboratory team at all the inpatient sites in the hospital prior to the development of the POCT program. The purpose of these surveys and site visits were to identify potential end users, optimize the use of the deployed equipment and identify the changes required to make the project efficient and effective by taking feedback from all concerned stakeholders

POCT IMPLEMENTATION

Organizational structure

While the nursing staff and physicians may understand the day-to-day operation and provision of results, the overall responsibility of POCT program generally lies with the laboratory director. Responsibilities of the clinical laboratory include organization and implementation of the program, performing technical and general oversight and clinical consultancy and ensuring quality assurance. Laboratory director ensure compliance with all applicable regulations, rules and standards. To successfully achieve POCT implementation in an institute, a multidisciplinary organizational approach is a prerequisite. First and foremost, a clear organizational structure should be put in place for appropriate functioning and optimum utilization of each POCT site .

A multidisciplinary team comprising of all stakeholders with representatives from Pathology, Material and Management Division (MMD), IT, Biomedical Engineering (BE) and Nursing was formalized for execution of POCT program at AKUH. The team presented the POCT program at the Joint Staff meeting of the institute for approval. Concerns that arose with POCT implementation, like problems with ensuring quality, potential conflicts of interest, and an uncertainty of the responsibility, were all addressed with the stakeholders and the POCT end-users.

POCT policies and procedures

As per CLSI guidelines quality management system approach was followed for the development of standards and policies for POCT program. The organizational and regulatory requirements that should be considered when implementing POCT program in an institute should all be documented . Laboratory director was made responsible for standards of performance in all areas, including quality control, quality assurance and test utilization in patient care. Each POCT site that performs POCT must have written policies and procedures available at the testing sites. Quality management plan, policies and testing procedures were written down and simultaneously POCT training program and curriculum were outlined by the pathologists and shared with POCT team members for approval and critique. Oversight and control of POCT program was hence provided by the laboratory directorship along with all necessary assistance to run this program smoothly. The laboratory in writing agreed that under this program, a standard package of POCT services can be provided at any clinical facility in the institute, as long as the required training, proficiency testing, quality control and validation procedures were performed, verified and documented.

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