MLS regulation and accreditiation

• Laws in Guyana pertaining to the Medical Laboratory include:

  • Ministry of Health Act
  • Health Facilities Licensing Act
  • Allied Health Professions Act
  • Occupational Safety & Health Act
• Ministry of Health Act:

  • Enacted December 1, 2005
  • Functions include regulating health care professionals, hospitals, and health facilities in the public & private sectors
• Health Facilities Licensing Act:

  • Enacted in 2007
  • This Act applies to a health facility or class of health facilities that is prescribed
  • No health facility can operate without a license issued by the Minister
• Allied Health Professions Act:

  • Enacted in 2010
  • Establishes the Allied Health Professions Council and outlines registration & licensing of allied health professionals
• Occupational Safety & Health Act:

  • Enacted in 1997
  • Provides for the registration and regulation of industrial establishments, occupational safety and health of persons at work
• Regulations for Medical Laboratories are outlined in the Health Facilities Licensing Act, covering staff, scope of service, specimen collection, records, policies & procedures, reportable diseases, and accommodation
• No Medical Laboratory should be used unless it is certified by the Guyana National Bureau of Standards
• Standards in Guyana for Medical Laboratories:

  • ISO 15189:2022
  • GYS 170:2021
• Certification is the evaluation and recognition of meeting pre-determined requirements or criteria, while accreditation assesses and recognizes that a health care organization meets applicable standards. This is a voluntary process unlike certification.
• Laws – the system of rules, or statutes, created by the Government of a country. Statutes are enacted by legislative bodies, then signed by the ranking official. Everyone must follow them to be legal.
• Regulations are detailed instructions on how laws are to be enforced or carried out; sometimes referred to as "admnistrated laws." They carry the force of law-their application is mandatory.
• ISO 15189:2022 is the accreditaion standard while GYS 170:2021 is the certification standard.