Ministry of Health
Supervised Antigen Testing / Fit to fly protocol
Title: SUPERVISED ANTIGEN TESTING/FIT-TO-FLY TEST CERTIFICATE PROTOCOL
Effective: March 1, 2022
Version: 1.2
1.
RECENT DOCUMENT CHANGES
Date of Change
Version
Nature and location of change
17 Jan 2022
1.0
First Version
19 Jan 2022
1.1
Clarification of Terms
1 Mar 2022
1.2
Inclusion to Waiver
2.
REFERENCES
Allied Health Professions Act 2018
Bermuda Health Council Act 2004
CDC’s Amended Global Testing Order; “Requirement for Proof of Negative COVID-19 Test or Recovery from
COVID-19 for All Air Passengers Arriving in the United States.”
ISO 13131:2021 Health informatics - Telehealth Services
ISO 15189:2012 Medical laboratories - Requirements for quality and competence
Medical Practitioners Act 1950
Public Health (Clinical Laboratories) Regulations 2002
3.
DEFINITIONS
Clinical Laboratory:
means a facility for the biological, microbiological, serological, chemical,
immunohematological, hematological, biophysical, cytological, pathological, or other examination of
materials derived from the human body for the purpose of providing information for the diagnosis,
prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings
Fit-to-Fly Certificate:
A medical certificate/letter certifying that the holder has recently tested negative for
COVID-19.
Health Professional (Bermuda):
means a person who is registered to practise his or her health profession by
the relevant regulatory authority
Health Service Provider (Bermuda):
means a person, group of persons or organization that operates a
business offering health services to the public, but does not include a person who is an employee under a
contract of service.
Healthcare Provider (USA):
Under US federal regulations, is a licensed or registered: doctor of medicine or
osteopathy, podiatrist, dentist, chiropractor, clinical psychologist, optometrist, nurse practitioner, nurse-
midwife, clinical social worker, (or other allied health professional) who is authorized to practice by the State
and is performing within the scope of their practice as defined by State law.
Registered Person:
means an exempted medical practitioner, a medical officer of the armed forces, a
registered medical practitioner, a specialist, a Government medical officer, an authorized visiting practitioner,
a locum tenens, a house officer, or any other person declared by the Minister by notice published in the
Gazette to be a registered person
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4.
PURPOSE
Per policy direction, this document serves to outline the eligibility requirements, approval process, and procedures governing
supervised antigen test certification in general and specifically the fit-to-fly certificate process for international travel. This
protocol is only in respect of testing for SARS-CoV-2.
5.
BACKGROUND
SARS-CoV-2 has prompted changes in travel requirements across the globe. For example, the CDC has determined a SARS-
CoV-2 test, no more than 1 calendar day before a flight from an international country, is necessary for all passenger,
regardless of vaccination status, to protect the public health of the United States. Such changes in testing requirements for
travel have added requirements to Bermuda’s COVID-19 testing infrastructure and the clinical laboratories that have
traditionally provided these services. In response, registered health service providers and their associated registered health
professionals are being granted the ability to conduct supervised SARS-CoV-2 antigen testing and issue fit-to-fly certificates
in an effort to meet testing capacity needs. This service of providing supervised antigen test is in respect of Bermuda Market
Authorized test kits that meet criteria of being “simple laboratory examinations and procedures that have an insignificant risk
of an erroneous result”.
6.
ELIGIBLE ENTITIES
A health service provider (business) or health professional (person) may provide supervised antigen testing and issue a fit-to-
fly certificates if the following conditions are met:
Have received regulatory approval to provide such services in Bermuda (See section 7).
The health professional must be registered, and in good standing with, one of the following Statutory Bodies
in Bermuda that govern the professions:
o
Bermuda Dental Board
o
Bermuda Medical Council
o
Bermuda Nursing Council
o
Bermuda Psychologists Council
o
Council for Allied Health Professions
o
Optometrists and Opticians Council
o
Pharmacy Council
The health professional must be associated with a health service provider that is registered with the Bermuda
Health Council.
Testing must take place at a facility or location that is registered with or approved by the Bermuda Health
Council.
There must be protocols in place to manage safety of both the persons performing the test and the persons
being tested.
The designated health professional must be clearly identifiable and accessible and have the competence to
ensure and take responsibility for all testing being performed (including staff training) and be available to
provide clinical advice when required.
The health service provider must ensure that staff performing or supervising the performance of the test are
trained in the correct performance and interpretation of the test including specimen collection. Note:
inadequate or incorrect sample collection can affect the accuracy of the test.
The privacy and confidentiality of individuals must be maintained at all times. Consent should be obtained
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from the individual to allow the collection and testing to be carried out.
Collection of specimens must be performed with accurate identification of the person being tested to ensure
traceability of specimen collection to final result.
If self-collection of a swab is necessary, this must be conducted under the supervision of a person who has
been trained in sample collection in order to verify patient identification and ensure an appropriate sample
is collected. Poor sample collection can result in false negative results.
The health professional must agree to follow Bermuda Health Council guidance as issued (inclusive of fit-to-
fly certificate format – Annex 3), reimbursement, and health safety directives).
If the method of service delivery is telehealth, the telehealth-related health service provider must, be locally
registered, and use an interactive audio and video telecommunications system that permits and
documents/records real-time communication between the patient and the observer, from sample collection
to result.
7.
APPROVAL PROCESS (HOW TO RECEIVE REGULATORY APPROVAL)
Each jurisdiction has may have unique requirements for reviewing SARS-CoV-2 test results for travel. This may include that
results come from a registered laboratory. As criteria for all jurisdictions may not be the same, the approval process for
providing supervised antigen testing for SARS-CoV-2 and for issuing fit-to-fly certificates include different options. As such, to
receive approval to conduct Supervised Antigen Testing for SARS-CoV-2 and issue fit to fly certificates, health service providers
and health professionals must:
Option 1: Be a registered clinical laboratory (See Annex 4)
Option 2: Have a documented partnership/affiliation agreement with a registered clinical laboratory, naming the health
professional as an external specimen collection site. In such agreements, clinical laboratories must inform the Bermuda
Health Council of all partnership/affiliation agreements, which will be listed on the Council’s website, here. In addition, clinical
laboratories must inform their accrediting agencies of each external partner/affiliation. Clinical laboratories will be
responsible for all testing conducted by their partners/affiliations, with possible implications to their continued registration
with the Bermuda Health Council. (See Annex 5)
Option 3: Health service providers and health professionals who meet all criteria under section 6 may seek a waiver from
laboratory affiliation from the Council, here. (See Annex 6)
8.
PUBLICATION OF APPROVALS
All approved health services providing COVID-19 antigen testing, and fit-to-fly certificates are listed on the Council’s website
here.
9.
ELIGIBLE TESTS
The test selected must be a viral test able to determine current COVID-19 infection. Eligible tests are limited to Bermuda
Market Authorized Antigen testing kits, as approved by the Bermuda Health Council, can be found here.
Please note that test eligibility is also limited to those accepted by the destination of travel. For example, in the US “viral
Click Here to Submit Application
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antigen test cleared, approved or issued an emergency use authorization (EUA) by the U.S. Food and Drug Administration, or
granted marketing authorization by the relevant national authority for the detection of SARS-CoV-2, performed in accordance
with the approval/clearance/EUA/marketing authorization.”
The Customs and Health Department has created the “COVID-19 Test Kit Pre-approval Process" to ensure importers of COVID-
19 related products receive speedy pre-approval.
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Annex 1: International Travel Requirements (Direct routes from Bermuda)
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Annex 2: Fit-To-Fly Certificate Format
A Fit-to-Fly Certificate may be issued in paper or digital form, and must include the following information:
Traveler Information/Identifiers
Name
Date of Birth
Passport Number
Travel Date
Traceable Certificate Number
Sample/Testing Information
Sample Collection Date
Test Type or Methodology
Test Kit Name/Manufacturer
Test Kit Lot Number
Start & End Time of Video Call (telehealth only)
Testing Facility Information
Collection Location
Affiliated Clinical Laboratory
Laboratory Registration Number
Testing Location (if different from collection site)
Test Reviewer Signature (Registered health professional)
Test Results
Must explicitly state the following: negative, RNA not detected, SAR-CoV-
2 Antigen Not Detected, COVID-19 Not Detected
Test marked “Positive” or “Invalid” are NOT acceptable
Note: all positive results must be reported to the appropriate authority
and are subject to the guidance issued by the Ministry of Health’s
regarding reflex RT-PCR testing, and quarantine requirements.
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Annex 3: Fit-To-Fly Certificate Template
COVID-19 TEST RESULT CERTIFICATE
Certificate Use (e.g., Travel)
Order No.
XXXXXXXX
Certificate No.
XXXXXXXX
PATIENT NAME Test Result: XXXXXXXXXXX
Sex:
M/F/Other
Test Type
Antigen
Date of Birth:
dd/mm/yyyy
Sample Taken:
dd/mm/yyyy at xx:xx xm
Passport Number:
xxxxxxxxxxx
Result At
dd/mm/yyyy at xx:xx xm
Facility
xxxxxxxxxxx
Certificate Issued
dd/mm/yyyy
National Provider Identifier:
xxxxxxxxxxx
Certificate Expiration
dd/mm/yyyy
Registration Number:
xxxxxxxxxxx
Accrediting Agency
xxxxxxxxxxxxxxxxxxxxxxx
Symptom Verification
- No recent symptoms associated with COVID-19, including but not limited to: high fever, cough, shortness of
breath, muscle pain, headache, sore throat or disturbance in sense of smell/taste.
- No evidence of an active COVID-19 infection on the test date.
- No reported recent contact with a case of COVID-19.
I can confirm that based on the above information, this patient did not have any evidence of an active
COVID-19 infection and is FIT TO FLY.
Reviewing Health Professional Name
Reviewing Health Professional Signature
Registration Number: xxxx
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Annex 4: Registered Clinical Laboratories
Reg. #
Facility
CL-001
BHB DEPTMENT OF PATHOLOGY
CL-002
ISLAND HEALTH SERVICES
CL-004
HOPE HEALTHCARE
CL-008
C & S WEST MEDICAL SERVICES
CL-010
FAMILY MEDICAL SERVICES
CL-011
MEDILAB
CL-012
POINT FINGER ROAD MEDICAL CENTER
CL-015
WOODBOURNE MEDICAL LABORATORY
CL-016
NORTHSHORE MEDICAL & AESTHETICS CENTER
CL-017
PREMIER HEALTH & WELLNESS
CL-018
HELIX GENETIC AND SCIENTIFIC SOLUTIONS
CL-019
HMC URGENT CARE & MEDICAL IMAGING
CL-020
BERMUDA MOLECULAR DIAGNOSTICS LABORATORY
CL-021
HAMILTON HEALTH CENTER
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Annex 5: Partnership Agreement
Partnership agreements may only be held between a registered clinical laboratory and a registered health service
provider, operated by a health professional, who is operating within his or her scope of practice, as outlined by
the appropriate statutory board.
This agreement states that the health service provider facility is an external specimen collection site, and subject
to all regulations governing the conduct of clinical laboratories. As such, a clinical laboratory may accept or deny
an affiliation request at their discretion.
The Health Council will hold the clinical laboratory responsible for testing related activities conducted at
partner/affiliation facilities, and may require the termination of a partnership agreement if deem necessary.
The clinical laboratory is to be responsible for documenting the following items below with its external site(s).
External sites are subject to operating within the parameters of this information, to which they must have access
to at all times:
o
List of Testing Personnel
o
Records of Training and Competency
o
Collaboration with Environmental Surveillance Unit and Ministry of Health
o
Quality Assurance Program
Internal and External Quality Control
Testing Validation
Proficiency Testing (evidence of enrollment and submission within 30 days)
o
Documented Policies and Procedures
Infection control
Pre-analytical processes (i.e. social distancing, patient registration, etc.)
o
Sample Management/Standard Operating Procedure Manual (site specific)
Sample Collection
acceptability criteria
rejection criteria
Sample Transport
Testing Procedure
Results Release
Sample Storage
Sample Destruction
Reflex and Positive Results Procedure
Trouble shooting, corrective, and preventive actions
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Annex 6: Waiver from Laboratory Affiliation
The Bermuda Health Council strongly recommends that testing health facilities be partnered with a registered clinical
laboratory to ensure the highest version of quality results. However, a health service provider may seek a waiver to provide
COVID-19 testing, and issue fit-to-fly certificates without such partnership.
Waivered facilities must agree to follow Bermuda Health Council guidance as issued (inclusive of fit-to-fly
certificate format, reimbursement, and health safety directives).
Waivered facilities must follow all manufacturer’s instructions in the performance of each testing procedure.
Additionally, all kits, reagents, and controls must be stored and handled in accordance to manufacturer
recommendations. No modifications may be made by the facility to the manufacturer’s procedure.
Quality controls (QC) must be performed and recorded per manufacturer’s instructions, and QC results must be
reviewed, and found to be acceptable prior to patient result reporting. If QC is not acceptable, patient results may
not be reported, and the cause of the QC failure must be investigated. All QC results must be reviewed monthly
and stored for 2 years.
Each facility is expected to maintain a current, accurate list of testing personnel. Each testing staff member must
have documented training, and a competency assessment in the testing procedure. These waivered facilities and
their associated health professionals must agree to be included on a publishable list of registered persons for the
purpose of providing supervised antigen testing and issuing fit-to-fly certificates.
The Council may conduct ad-hoc site visits to ensure all requirements are met. The Council may also remove a
facility’s or professional’s testing approval for non-compliance or upon change to policy at its discretion.