Laboratories to be audited

Robin Muchetu, Senior Reporter

MEDICAL laboratories, including those that sprouted following the emergence of Covid-19 in Zimbabwe, will be subjected to an audit to ensure they are working within the stipulated parameters, standards, and regulatory frameworks in an effort to maintain best practices and standard operating procedures.

This was said by the National Certification Coordinator for the Medical Laboratory and Clinical Scientists Council of Zimbabwe, Mr Luxury Shonhiwa who is in charge of the certification process where 50 public and three private laboratories have been audited so far.

During the height of the Covid-19 pandemic, there was an upsurge in the number of laboratories that opened to offer testing facilities for Covid-19 as the tests were mandatory for traveling, entry into workplaces, and various other areas.

“There are a lot of labs that opened recently, especially with the advent of Covid-19, and most of those labs were not meeting the required minimum quality standards that the council requires.

So, we have come up with a new programme called the Zimbabwe National Certification Programme. We have set minimum standards; we came up with certification framework that looks at the standards of those laboratories,” said Mr Shonhiwa.

This national certification framework will see all laboratories being audited by the council with a checklist looking at the minimum quality standards.
“We give them levels from level zero to level five depending on how good they will have scored during the audit that looks at the minimum quality standards that we want.

Level zero is good as there is no laboratory at all while five will indicate the best standards. After the audit we will then give them a certificate for the level achieved,” said Mr Shonhiwa.

Laboratories that are classified as level zero do not get any certification and must close. The council said they would give laboratories colour-coded certificates that must be displayed where clients, patients, doctors, and any other person can see in order for them to make a choice on accessing services there.

“If a patient realises that the laboratory they have visited is operating with a red level one certificate they know they are not getting the best from that place and can make an informed decision to access a laboratory with better certification.

We really want all the labs to be audited. We have certificates from colour red all the way to colour green, levels that are classified level one is considered okay, but not what is expected by the council. These will get a red certificate, level five at the top most will be green in colour and is valid for five years.

However, we will do mandatory surveillance audits every year to see if the laboratories are improving on quality,” he said.
The council said they were not only targeting laboratories but would also audit point-of-care testing sites that do testing for HIV testing only. Mr Shonhiwa said they were hoping to rope in the Association of Healthcare Funders in Zimbabwe, Health Professions Authority in Zimbabwe, and medical aid societies.

So far, the council have not yet ordered any laboratories to close but they have indicated areas of improvement and given time for those that have been audited to conform and get a better level.

Medical Laboratory and Clinical Scientists Council of Zimbabwe said the checklist that was being used to audit the laboratories included documents and records. They expect laboratories to document all that they do.

The second section is the facility itself where they look at equipment, space, and biosafety checks to see if the laboratory will not contaminate those coming to seek services and how the waste is disposed of.

He said there were strict measures that must be taken when disposing of that waste and must not be mixed with the waste collected by the local authority.

“We need to see how well the results are documented in order for them to get to the clinicians as they should be and at what time, as time frames are important. Some tests take just 30 minutes to be processed but some labs tell you to return more than 5 hours later, which is not correct as some results end up being meaningless as they will have taken too long to get to the clinician and remain relevant,” added Mr Shonhiwa. -@NyembeziMu