QALS Partners

02/05/2020

The Bahamas National Laboratory Testing Strategy (Latest Developments)

During the latest Ministry of Health (MOH) COVID-19 News Conference, Thursday, April 30, 2020, the update outlined modifications in the testing capacity, in respect to the national laboratory testing strategy and response to the COVID-19 Pandemic in the Bahamas.

THE MOH INSTITUTED A FIRM POLICY THAT NO RAPID ANTIBODY TESTING WILL BE ACCEPTED IN THE BAHAMAS TO CONFIRM THE NEGATIVE OR POSITIVE STATUS OF COVID-19 PATIENTS. HENCE, RESULTS PRODUCED FROM SUCH TESTING ARE DEEMED NOT ACCEPTABLE IN THE BAHAMAS.

The MOH, in its capacity of regulatory oversight, while utilizing quality assurance measures, primarily the internal, in-country validation of clinical testing, had determined that the rapid antibody testing for the purpose of diagnosing COVID-19 in the Bahamas is unreliable or inaccurate.

When asked about the use of the rapid antibody testing, Dr. Merceline Dahl-Regis, a former Chief Medical Officer (CMO) of the Bahamas, a public health expert and a healthcare consultant to the Office of the Prime Minister, confirmed that, “yes, they were used. There were false positives and false negatives and this has impacted the spread of infection among healthcare workers.”

** The accredited National Reference Laboratory (NRL) performs the gold standard of diagnostic testing for COVID-19, the Real-time Polymerase Chain Reaction (RT-PCR). The NRL has been certified by WHO/PAHO and has been deemed by the Ministry of Health, as the only laboratory in the Bahamas with the technical capability to perform such testing. **

** As of Thursday, April 30, 2020, the NRL has the current testing capacity for COVID-19 of less than 4,000 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. **

With “ramping up” of testing now the primary goal of the response, the Caribbean Public Health Agency’s (CARPHA) Medical Microbiology Laboratory (CMML), 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.

25/04/2020

Quality assurance in COVID-19 testing, specifically antibody tests or "rapid tests", is vital to public health, as it provides confidence to not only the healthcare provider, but to the general public.

A team of scientists worked around the clock to evaluate 14 antibody tests. A few worked as advertised. Most did not.

24/04/2020

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.

22/04/2020

UPDATE: The Bahamas National Laboratory Testing Strategy in Response to COVID-19 (Part 3 and 4)

Today, Wednesday, April 22, 2020, the Extraordinary Official Gazette of the Bahamas published the Emergency Powers (COVID-19) (Amendment) (No. 5) Reguations, 2020, in response to the novel coronavirus disease (COVID-19) pandemic. https://opm.gov.bs/emergency-powers-covid-19-amendmentno-5-regulations-2020/

Regulatory Oversight

** By the Emergency Powers (COVID-19) (Amendment) (No. 5) Reguations, 2020, 6A. Regulation of Care, “the Competent Authority may by order, regulate the sector of persons providing medical, therapeutic and other patient care.” The Competent Authority, or the Office of the Prime Minister, may assume the role and responsibilities of technical and professional regulatory authority for the ENTIRE healthcare system of the Bahamas. **

This is a major development, in the response to the novel coronavirus disease (COVID-19) pandemic and the national laboratory testing strategy. In other words, the Ministry of Health, the Department of Public Health, the Public Hospitals Authority, as well as, regulatory agencies and councils of healthcare services, such as the Hospital and Healthcare Facilities Licensing Board, the Medical Council, the Health Professions Council and their respective executives, even the National Reference Laboratory, the Princess Margaret Hospital and private healthcare facilities, may be directed and governed solely by the Competent Authority, as deemed applicable, in respect to the provision and regulation of healthcare in the Bahamas.

22/04/2020

The Bahamas National Laboratory Testing Strategy in Response to COVID-19 (Part 4)

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

By the Proclamation of Emergency and subsequent Emergency Powers (COVID-19) Regulations, 2020, the Office of the Prime Minister was deemed the Competent Authority. The Minister of Health, the Managing Director of the Public Hospital Authority (PHA) and the person charged with responsibility for directing the day-to-day operations of any other entity or public body charged with responsibility for protocols with respect to COVID-19, shall report to the Competent Authority, during the continuance of the public emergency.

Prior to the COVID-19 Pandemic

The Bahamas was ranked 94th in the world’s health systems and one reason for such a ranking is that the standards and regulation of healthcare in the Bahamas do not meet international standards, in respect to conformity assessment. Self-policing and internal auditing, for example internal validation of testing, by public and private healthcare providers has been the strategy used and relied upon by governing agencies, such as Hospital and Healthcare Facility Licensing Board and the PHA.

This methodology of quality assurance in healthcare has proven to be inadequate by various international reports and studies, primarily due to conflicts of interests, fear of retribution (silence) and competency maintenance. Even though technical regulations and laws in healthcare have been enacted in which provisions are made, the lack of implementation and enforcement of public policies has diminished the effectiveness of their purpose, in assuring the quality of care given to the general public of the Bahamas.

In Response to the COVID-19 Pandemic

On March 11, the World Health Organization (WHO) officially classified the global spread of COVID-19 as a pandemic. The Office of Prime Minister established the National Coordination Committee on COVID-19 (NCCC), which is co-chaired by the Chief Medical Officer (CMO) of the Bahamas. “In addition to serving as a coordination and steering committee, the NCCC will also engage with the COVID-19 multi-governmental agency task force to implement decisions of The Bahamas government, recommend policies to the Cabinet and provide sector and society impacted analysis and feedback to Cabinet, as applicable.”

On March 17, the Governor General signed a proclamation declaring a public state of emergency, in which the Office of the Prime Minister was deemed the Competent Authority. Around this time, the services of Dr. Merceline Dahl-Regis, a former CMO of the Bahamas, a public health expert and chairperson to WHO's Global Validation Advisory Committee, was enlisted as a healthcare consultant to the Office of the Prime Minister. In this role, she has become the lead in the national health response to COVID-19 in The Bahamas and the liaison to the Competent Authority, providing guidance and oversight to all aspects, including the National Laboratory Testing Strategy, in which her affiliation with WHO/PAHO assisted in the adherence of international regulations and standards in the diagnostic testing and reporting of COVID-19.

21/04/2020

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.

20/04/2020

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.

20/04/2020

The Bahamas National Laboratory Testing Strategy in Response to COVID19 (Part 1)

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 Capacity

The term “testing capacity” has been used extensively by the MOH and has become a buzz-word or a word or phrase, that is fashionable at a particular time or in a particular context, such as the COVID19 Pandemic. In this regard, “technical capacity” in the Bahamas has been relayed as 1) the amount of tests in the country, 2) the amount of tests that can be performed daily and 3) the turn-around-time (TAT) of the testing, once in the laboratory.

** As of Thursday, April 16, 2020, the current testing capacity for COVID-19 in the Bahamas is 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. **

The internationally recognized gold standard of detecting the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a patient for confirmatory diagnostic testing is the molecular genetic testing, Real-time Polymerase Chain Reaction (RT-PCR). The Applied Biosystem® 7500 Real-Time PCR System is being utilized in the Bahamas, which includes one (1) analyzer, COVID-19 primers, probes, extraction kits and detection kits. This testing is performed for suspected COVID-19 cases in the Bahamas and the Turk and Caicos Islands.

Serologic or antibody testing, publicly understood as the “rapid test” is the other method of testing for COVID-19. In the country, there are currently 10,000 rapid kit tests, plus 5,000 more recently donated by Island Luck to the MOH, from a variety of unnamed manufacturers and distributors. The Minister of Health, Dr. Duane Sands, has described these rapid tests as “not ready for primetime” and “worthless”. He further explained that, to date, none have met the criteria to be “validated internally” or “validated in country” for use, due to the inaccuracy and unreliability of the results.

With any shift in the National Laboratory Testing Strategy, as previously suggested by Dr. Sands, the Caribbean Public Health Agency’s (CARPHA) Medical Microbiology Laboratory (CMML), 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.

19/04/2020

24/03/2020

Laboratory Testing Strategy Recommendations for COVID-19, Interim Guidance, 22 March 2020
https://apps.who.int/iris/bitstream/handle/10665/331509/WHO-COVID-19-lab_testing-2020.1-eng.pdf

We, at QALS Partners, are willing and available to serve, standing in unison with every citizen, the Ministry of Health and the Government of the Bahamas to achieve our desired outcome, as we strive to sustain and move our healthcare system and country, forward, upward, onward, together.

26/11/2019

The Quality Factor (The Q-Factor)

Six Sigma is a quality assurance strategy used by many leading global companies such as Amazon, the Ford Motor Company and Dell. It is called Six Sigma because of the strategy’s heavy dependence on statistical tools. The name refers to six standard deviations between average and acceptable limits ...

28/10/2019

Preparation is key ..... Acknowledging the shortfalls and problems that exist in a system is the first step in accepting that change is necessary for improvement in it.

https://thenassauguardian.com/2019/10/28/bahamas-among-nations-least-prepared-for-pandemics/?amp