Ethics and Concerns

Mandatory testing has, in the past, not been supported by the Canadian Medical Association. Testing without informed consent has been viewed as unethical and unjustified. It has been suggested that mandatory testing and disclosure would infringe on personal autonomy, and may be a violation of rights enshrined in the Canadian Charter of Rights and Freedoms.

The legislation is complex, and likely will be interpreted by the courts via appeals. There are several outstanding issues and concerns.

The actual transmission of a bloodborne illness in an occupational setting is rare. Blood test results are usually not available in a timely enough way to guide the initial risk assessment and management decisions regarding HIV post-exposure prophylaxis. If blood test results from the source are available, negative results do not guarantee zero risk. Incubation periods vary. For example, an individual’s blood may not show evidence of the HIV antibody for a period of 3 to 6 months after being infected (commonly referred to as the “window period”).

The current approach is to ask for voluntary blood testing from the source. The order would render this a mandatory process, not requiring the consent of the individual. There are concerns about the ethics and legality of compelling the testing. There are also concerns regarding confidentiality since the respondent’s test results will be provided directly to the applicant’s physician.

What are the risks of bloodborne transmission during an exposure?

Hepatitis B
The risk of transmission varies depending on the degree of contact with blood and the Hepatitis B e antigen (HBeAg) status of the source person.

Studies have shown that for unvaccinated health care providers (HCP) who had injuries from needles contaminated with blood that was both hepatitis B surface antigen (HBsAg) and HBeAg-positive, the risk of developing clinical hepatitis was 22 to 31 per cent, while the risk of developing serologic evidence of HBV infection was 37 to 62 per cent.

For injuries from needles contaminated with blood that was HBS-Ag-positive and HBeAg-negative, the risk of developing clinical hepatitis was 1 to 6 per cent, while the risk of developing serologic evidence was 23 to 37 per cent.

Hepatitis C
The risk of infection for HCV from a single percutaneous exposure is estimated at 1.8 per cent (range: 0 to 7 per cent). The risk from exposure following mucous membrane or non-intact skin exposure is unknown, but believed to be very low.

HIV
The risk of transmission from a single percutaneous exposure to HIV is estimated to be 0.3 per cent,, while the risk from a mucous membrane exposure is estimated at 0.09 per cent. The risk of transmission through non-intact skin is unknown but felt to be less than that from mucous membrane exposure.

Reference
Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis June, 2001

Roles for physicians and Nurse Practitioners

As a physician, your role may vary within the process.

Nurse practitioners or physicians may take blood in the voluntary process or in the event of an order. However only physicians are able to complete the physician report.

• You are usually the physician involved in the assessment and management of the applicant’s exposure. You may be the family doctor or another physician sought out by the applicant within seven days of the exposure to complete the physician report.

   

• You are asked by the applicant to assist in his or her application process by completing the Physician Report. To meet the requirements of the legislation it is critical that all fields are completed on the form. An incomplete form may result in a dismissal of an application. The following information is required:

(a) the name, office address, office telephone number and office fax number of the reporting physician;

(b) the applicant’s name, address, telephone number, OHIP number, sex, age and date of birth;

(c) the name, office address, office telephone number and office fax number of the applicant’s family physician, if different from the reporting physician;

(d) a description of the occurrence, including the date and time of the occurrence;

(e) a statement regarding the type of exposure the applicant experienced and the type of bodily substance with which the applicant had contact;

(f) the reporting physician’s findings of examinations related to the occurrence, including an assessment of any injuries sustained by the applicant;

(g) the applicant’s immunization history and serostatus for the listed communicable diseases, if known;

(h) a description of all baseline testing for the listed communicable diseases ordered by the reporting physician and, if the applicant refused any such baseline testing, a description of the baseline testing that the applicant refused;

Note: A reporting physician shall order baseline testing of the applicant for all of the listed communicable diseases; however, a reporting physician is not required to order baseline testing for a listed communicable disease if the reporting physician has other evidence, satisfactory to the reporting physician, of the applicant’s serostatus respecting that disease.

(i) a description of all prophylaxis and treatment recommended by the reporting physician, including a statement regarding whether the applicant refused any such prophylaxis or treatment;

(j) a statement that the applicant consented to counselling respecting the occurrence, including counselling respecting prophylaxis and treatment;

(k) the name, office address, office telephone number and office fax number of the physician or physicians to whom the reporting physician referred the applicant for prophylaxis, treatment and follow-up, if applicable; and

(l) the reporting physician’s assessment of the applicant’s risk of exposure to the listed communicable diseases as potentially significant, non-significant or indeterminate;

(m) the signature of the reporting physician and the date signed

The physician completing the physician report may bill OHIP for this service

• You may be named as the applicant’s physician or nurse practitioner by the applicant on the applicant report. This person can be different from the reporting physician and can therefore receive blood test results from the baseline testing requisitioned by the physician who completed the physician report. Where the respondent volunteers to testing, the results will be shared with you by the medical officer of health and follow-up with the applicant can then be provided. If the voluntary process is unsuccessful and the Consent and Capacity Board is required to order the testing of the respondent’s blood, the results will be delivered to you directly from the Central Public Health Lab.

• You may be the respondent’s physician or nurse practitioner in the voluntary process. The respondent may request from you that blood tests for hepatitis B, C or HIV be done or ask that evidence of recent testing be released from you to the health unit. This is part of the voluntary process where the respondent provides consent for the disclosure. The public health nurse from the health unit will work with you and the respondent around these steps, providing you with additional information and the signed consent when evidence of recent testing is available.

• When the respondent is willing to voluntarily submit to blood testing, the public health nurse will provide him/her with the Ministry of Community Safety and Correctional Services laboratory requisition. The respondent will go to you, a local lab or to the sexual health clinic at the health unit for testing.

• Where you are named on the requisition for the voluntary process, you will receive a copy of the test results for your records. The medical officer of health holds the responsibility for sharing the results with the applicant’s physician.

• A respondent may give your name as the person to take the blood when an orderisissued by the Consent and Capacity Board.

• Whether you are asked to take blood from the respondent who volunteers or the respondent who is ordered, the processes are the same. You will be provided with the specific Ministry of Community Safety and Correctional Services laboratory requisition and required to follow the requirements as stated on the requisition.

• Hepatitis B surface antigen (HBsAg)
• Antibody to Hepatitis C virus (anti-HCV)
• HIV

The specific instructions for taking and processing the sample are written on the lab requisition and require you to:

• verify the respondent’s identification with photo id or two pieces of signed identification
• print your name and address in the field marked “respondent’s physician” on the laboratory requisition
• take two vacutainers of blood from the respondent
• print the respondent’s full name and date of birth on each vacutainer
• attach a unique number sticker from the seal to each vacutainer
• place the two vacutainers in the biohazard bag provided and attach a seal to the bag
• attach a unique number sticker from the seal to each of the three copies of the lab requisition
• complete, sign and date the field “to be completed by the physician who takes the blood sample” on the requisition
• give one copy of the completed requisition to the respondent and retain one for your records
• courier one copy of the requisition and the two vacutainers in the sealed biohazard bag via Purolator Courier to:

Central Public Health Lab
81 Resources Road
Etobicoke, Ontario
M9P 3T1

• You will receive copies of the blood test results, however as for the voluntary process, the medical officer of health holds the responsibility for sharing the results with the applicant’s physician.