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Medical labs still operating without specific regulation

Published:Tuesday | December 1, 2015 | 12:00 AMEdmond Campbell
Monroe Ellis

MEDICAL LABORATORIES in Jamaica have been operating without a specific regulatory regime despite the passage of the Health Facilities (Medical Laboratories) Act and subsequent assent by the governor general 10 years ago.

Auditor General Pamela Monroe Ellis says the laboratories continue to operate without the required regulatory framework because the Health (Medical Laboratories) Act was not gazetted and brought into operation.

This is contained in an activity-based audit report of the National Public Health Laboratory (NPHL). The audit was conducted by the auditor general and the report was tabled yesterday in Parliament.

Section 1 of the Health Facilities (Medical Laboratories) Act states that the act "shall come into operation on a day to be appointed by the minister by notice published in the gazette".

However, the notice was not published in the gazette.

The auditor general says that she was advised that both the act and the draft regulations were being reviewed by the Ministry of Health's legal unit because based on the issues to be captured in the regulations, the Health Facilities (Medical Laboratories) Act would need to be amended before promulgation.

In the absence of the Health Facilities (Medical Laboratories) Act, the health ministry said the labs are monitored under the Public Health Act and the Quarantine Act. It also pointed out that its Standards and Regulations Unit conducts periodic inspections of both public and private labs to determine whether certain public-health standards are met.

The auditor general reported that the NPHL applied for accreditation for some of its activities in November 2013 as the Medical Laboratories law had not been promulgated.

Accreditation was sought for haematology, phlebotomy, clinical chemistry, sample reception, and emergency laboratory.

The NPHL provides laboratory services for clinical- and public-health interventions, as well as support to the Regional Health Authorities. It provides particular clinical laboratory support to the Kingston Public Hospital and Victoria Jubilee Hospital and other health institutions within the South East Regional Health Authority and the rest of the national public health system as required.

However, the local accreditation body, the Jamaica National Agency for Accreditation (JANAAC), assessed the NPHL in December 2014 and identified 31 areas across all the departments that had been assessed where the NPHL's systems were inadequate and did not conform to the requirements of the relevant international standard.

Monroe Ellis said the NPHL subsequently took corrective action to address seven of the non-conforming areas, while the other 24 were in various stages of reform.

"We were subsequently advised that another follow-up review was conducted by JANAAC in September 2015, leading to the closure of most of the non-conformities," the auditor general said.