A. Introduction

Accreditation in the healthcare has proven to be a driving force in improving quality care delivery to the patient. The shift in focus on improving standards in the medical laboratory community has had a constructive long-term impact on quality, cost-effectiveness, improvement and reliability. The standards in the medical laboratory would provide aid in identification, guidance and improvement on areas in a systematic and strategic manner.

The standards identify those aspects of program structure and operation that the HCAC regards as essential to program quality and achievement of laboratory health care goals.

They specify the optimal requirements for programs to ensure quality services related to patient management including patient care and the outcomes of the care, patient satisfaction, and patient safety. It also serves as an education guide for facilities that wish to establish new programs or improve existing programs.

B. Aim

The Medical Laboratory Accreditation Standards are intended to fulfill the following objectives:

• To reduce the potential errors that might occur in the medical laboratory processes.
• To improve the outcome in providing quality results that plays a major role in high quality patient care.
• To improve outcomes of treatment and management of priority diseases and conditions,
• To provide maximum patient satisfaction
• To ensure employees and client’s safety.

C. Framework of HCAC Medical Laboratories Standards

The HCAC Medical laboratory Accreditation Standards provide the guiding framework within which laboratory performance is evaluated, the standards specify quality management essentials in the laboratory that in total form quality management system along with competency requirements for medical testing, the standards are built using the WHO Laboratory Quality Stepwise Implementation Tool (LQSI).

A laboratory, just like any other organization, consists of numerous processes in which inputs are turned into outputs through one or more process steps. The core process of the laboratory is the primary process consisting of three stages: thepre-analytical stage(the sample is collected, received at the laboratory, registered and processed), theanalytical stage(the actual laboratory test is performed and the result is recorded), and thepost-analytical stage(the result is authorized, reported and archived and the sample is discarded/ archived).^[1]

A quality management system can be described as a set of building blocks needed to control, assure and manage the quality of the laboratory's processes. By ensuring that all the processes related to the QSEs perform correctly, quality can be assured.

Guiding Principles - Medical Laboratories incorporate the principles of:

• Health is a basic human right.
• Accuracy – delivering accurate results that have a significant impact in decreasing testing errors and enhancing patient treatment in a timeless manner.
• Quality Improvement–Assure and manage the quality of laboratory processes
• Evidence based practice - Services are provided according evidences from scientifically credible research
• Safety-Patients, staff and community have the right to safe care and treatment

D. Eligible Institutions

E. Organization of the standards Manual

The standards will provide medical laboratories with a framework for addressing service delivery and coordination, planning, policy, management and the relationship with other service providers and the wider community. The standards introduce the most important elements of patient safety to a medical laboratory and create the capacity for the medical laboratories to continually improve its quality of services to benefit patients

The standards are organized into key functions referred as “clusters”, they are divided into seven clusters. The clusters are arranged as follows:

Cluster 1: Governance and Leadership

Cluster 2: Human Resources Management

Cluster 3: Medical Laboratory Operations

• Laboratory workflow “Pre-analytic, analytic, post-analytic”
• Laboratory Equipment
• Quality Control
• Procurement and Inventory Management

Cluster 4: Medical Laboratory Facilities and Premises

• Facility & Premises
• Laboratory Safety
• Infection prevention and Control
• Emergency management

Cluster 5: Client Rights

Cluster 6: Quality Improvement

Cluster 7: Laboratory information management

• Laboratory Information System

For each cluster, there is an intent statement that assists the laboratory staff members to understand the standards and a list of the key documents that are required for review by the surveyors. In each cluster, every standard is listed followed by the measurable elements, and survey process. The survey process is identical to what the surveyors will look for to determine how to score the standard.

F. Classification of standards

As part of HCAC standardization approach, standards classifications among HCAC’s different accreditation standards will be unified; in order to maintain the same methods across all different types of standards. Therefore, laboratory standards were reclassified as critical, core, and stretch.  The guiding definitions are as follows:

Critical (12 Standards)

Critical standards are those standards that address laws and regulations or, if not met, may cause death or serious harm to patients, visitors, or staff.

Core (63 Standards)

Core standards are the standards addressing systems, processes, policies and procedures that are important for patient care. However, partially met compliance with these standards must not pose a threat of harm or death for patients, visitors or staff. 

Stretch (10 Standards)

Stretch standards are standards that are important, but not easy to implement due to time or resource constraints, or a need for culture change