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The Bahamas National Laboratory Testing Strategy, in Response to COVID-19 (Part 5)

During the latest Ministry of Health (MOH) COVID-19 News Conference, Thursday, April 16, 2020, the expansion of testing was highlighted, in respect to the MOH’s response to the novel coronavirus disease (COVID-19) pandemic.

** The Minister of Health, Dr. Duane Sands, stated “one of the linchpins in the evaluation of COVID-19 is laboratory testing. The World Health Organization and other leading health institutions support enhanced testing capabilities.” He further expressed that, “to determine our COVID-19 positive cases and to gauge community spread, it is important to have a sustained testing mechanism.” **

Initial Targeted Demographic Groups
- Persons who suffer from symptoms of COVID-19
- Contacts of Active COVID-19 Positive Cases

Testing Expansion

Dr. Sands elaborated that "the MOH is planning testing expansion in at-risk populations such as contacts of active cases, nursing homes, the prison and with healthcare workers. Expanded testing is critical for us to have an increased understanding of the pandemic in the Bahamas so we can plan and prepare to protect these vulnerable populations.”

Expanded Targeted Demographic Groups
- Persons who have symptoms of COVID-19
- Contacts of Active COVID-19 Positive Cases
- Exposed Healthcare workers of Active COVID-19 Positive Cases
- Persons working at and are in assisted living (nursing homes, rehabilitation centers, etc.)
- Persons working at or are in prison
- Persons whom are being removed from self-isolation and quarantine measures

The National Reference Laboratory is the only laboratory in the Bahamas with the technical capability to perform diagnostic testing for COVID-19 with a current testing capacity of 7,000 tests, at a rate of 50 per day, with an estimated 24-48 hour turn-around-time (TAT). Limitation to this testing is the availability of nasopharyngeal and throat swabs for specimen collection.

As previously suggested by Dr. Sands, the Caribbean Public Health Agency’s Medical Microbiology Laboratory, located in Trinidad and Tobago, may be utilized and serve as a means to augment any testing capacity and/or testing capability shortfall of the Bahamas, as it is the only CARICOM regional reference laboratory accredited to specifically test for COVID-19.

The Bahamas National Laboratory Testing Strategy in Response to COVID-19 (Part 3)

During the latest Ministry of Health (MOH) COVID-19 News Conference, Thursday, April 16, 2020, the focus was on the national laboratory testing strategy, which is 1) the testing capacity 2) the testing capability and 3) regulatory oversight, in respect to the MOH’s response to the novel coronavirus disease (COVID-19) pandemic.

Regulatory Oversight

** The MOH has assumed the role, as the lead regulatory authority and oversight of hospital, healthcare facilities, laboratories and healthcare professionals. The MOH has deemed the National Reference Laboratory, an accredited laboratory that employs certified laboratory professionals, as the only laboratory in the Bahamas to perform diagnostic testing for COVID-19, in an effort to ensure a higher degree in testing capability. **

To demonstrate a higher degree in testing capability of a laboratory,
1) accreditation is obtained for the physical facility and its quality management system;
2) whereas, certification is achieved by laboratory professionals.
Accreditation and certification are both done through third-party standards compliance and competence assessment.

Prior to the COVID-19 Pandemic

In the Bahamas, medical laboratory testing capability is governed by two statutory bodies, which are independent of the MOH:
1) the Hospital and Healthcare Facilities Licensing Board;
Responsible for the licensing and inspection of hospitals and healthcare facilities, as well as, for the initiation of investigations into any matter affecting the management, diagnosis or treatment of a person within a hospital or healthcare facility
2) and the Health Professions Council.
Responsible for the registration and licensing of health professionals and for the establishment of standards in qualifications, in order to govern, discipline and regulate the professional conduct of said health professionals.

1) Neither accreditation of a laboratory recognized by the Hospital and Healthcare Facilities Licensing Board, 2) nor certification of laboratory professionals acknowledged by the Health Professions Council, are requirements 1) for a laboratory to operate and 2) for laboratory professionals to perform clinical testing in the Bahamas, respectively.

In Response to the COVID-19 Pandemic

The Government of the Bahamas, under the purview of the MOH, has assumed some responsibilities from the Hospital and Healthcare Facilities Licensing Board and the Health Professions Council. As stated by the Minister of Health, Dr. Duane Sands, the MOH will inspect healthcare facilities that have been compromised by COVID-19 positive cases before services can resume at such places. The MOH has also restricted healthcare facilities, laboratories and healthcare professionals from the use and performance of all tests for the diagnosis of COVID-19 in the Bahamas, without first gaining the MOH’s approval.

Quality assurance, including the internal, in-country validation of “rapid tests” and external oversight of this testing, is a vital component in the Bahamas National Laboratory Testing Strategy in Response to COVID-19. The WHO/PAHO has certified personnel of the National Reference Laboratory to perform diagnostic testing of COVID-19. As previously suggested by Dr. Sands, CARPHA’s Medical Microbiology Laboratory (CMML) may be utilized to augment any testing capacity and/or testing capability shortfall of the Bahamas, as it is the only CARICOM regional reference laboratory accredited to specifically test for COVID-19.

The Bahamas National Laboratory Testing Strategy, in Response to COVID-19 (Part 2)

During the latest Ministry of Health (MOH) COVID-19 News Conference, Thursday, April 16, 2020, the focus was on the national laboratory testing strategy, which is 1) the testing capacity 2) the testing capability and 3) regulatory oversight, in respect to the MOH’s response to the novel coronavirus disease (COVID-19) pandemic.
Laboratory Testing Capability

In terms of testing capability, a laboratory comprises of two parameters: 1) the physical facility and its operational system; 2) and the laboratory professionals.

A laboratory’s testing capability can be described as its ability to meet and comply with industry standards and best practices in quality, safety and competence requirements, while producing consistently accurate and reliable results.

** The National Reference Laboratory (NRL) has been deemed by the Ministry of Health as the only laboratory in the Bahamas with the technical capability to perform diagnostic testing for COVID-19. Dr. Sands expressed that “all other tests for the diagnosis of COVID-19, outside the purview of the MOH, must first be approved for use in the Bahamas.” **

The NRL (also known as the HIV Reference Laboratory) has been accredited by the College of American Pathologists (CAP), since 2013. Its primary function is to perform HIV testing for the diagnosis, treatment and management of HIV positive persons throughout the Bahamas and for research in HIV and AIDS. Its secondary function is to be the national focal point in testing, research and response to epidemics and pandemics such as COVID-19.

As it relates to other recent viral outbreaks, such as Dengue, Chikungunya and Zika, the MOH’s position on testing capability has been different. Clinical laboratories in the Bahamas were allowed to independently procure, “internally validate” and perform testing, inclusive of “rapid tests”, and report results to healthcare providers and oversight entities, such as the Bahamas Department of Public Health and the Caribbean Public Health Agency (CARPHA) for the purpose of these diagnoses and mandated data collection, respectively.

The limitation of clinical testing is a major deviation from the contemporary healthcare and regulatory policy in the Bahamas. However, in these circumstances, it is understandable that the MOH would minimize variables in testing, while providing oversight . Inaccurate reporting of COVID-19 cases may have dire ramifications to not only the health and economy of the Bahamas, but in the perception and credibility of the Bahamas to the international community.

CARPHA’s Medical Microbiology Laboratory (CMML) may be utilized to augment any testing capability shortfall of the Bahamas, while Bahamian clinical laboratories are restricted from COVID-19 testing.