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.
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