Case study: achieving ISO-15189:2012 accreditation to perform COVID-19 testing

Medical diagnostic laboratory business consulting case study

Client profile:

A mid-size medical diagnostic laboratory in Jamaica, which prior to seeking consultation was performing only clinical chemistry, immunoassay, hematology and microbiology tests.

Reason for consultation:

Achieving industry certification and regulatory compliance. The client felt unprepared for the upcoming JANAAC inspection for ISO-15189:2012 accreditation. This accreditation was crucial for becoming qualified to perform COVID-19 testing, and the client wanted to become accredited as soon as possible.

Our assessment:

We conducted a complete review of all policy and procedure documentation, staff training records, infection control records, actual workflows, physical laboratory layout as well as available material and equipment.

We found that:

  • Most procedures and workflows were not documented;
  • There was no quality assurance program in place;
  • The laboratory layout and workspace were not consistent with COVID-19 testing requirements.


  • Drafted most of required documents, and assisted the client in drafting the remaining documents;
  • Created quality assurance checklists and the documentation review schedule;
  • Brought in a pre-screened and qualified contractor to modify the physical layout of the laboratory to optimize the air flow, patient flow and workspace ergonomics.


  • The client passed the JANAAC inspection on the first attempt;
  • The client began performing COVID-19 testing and significantly boosted their revenues;
  • The client became a referral center and now performs COVID-19 testing for other laboratories in the local area

2 thoughts on “Case study: achieving ISO-15189:2012 accreditation to perform COVID-19 testing

    • admin says:

      Thank you for your comment, Suzanne. We’ll be posting more case studies soon, hope you find them interesting!

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