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MINISTRY OF HEALTH

SOP Title: : Post - Exposure Prophylaxis. Version 1


SOP No: LGEN. 0023

xxx County.
Standard Operating Procedure. SOP No: LGEN.XXX
Facility;………………………..
Version: 1.
Supercedes: N/A.
Effective Date:XXX

Title: Post - Exposure Prophylaxis (PEP)

NAME. SIGNATURE. DATE.

PREPARED BY.

REVIEWED BY.

APPROVAL
AUTHORITY.

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
MINISTRY OF HEALTH

SOP Title: : Post - Exposure Prophylaxis. Version 1


SOP No: LGEN. 0023

1.0 PURPOSE / INTRODUCTION:


1.1 Health Care Workers (HCWs) are at risk of exposure to potentially infectious
materials through contact with contaminated blood and other body fluids through
needle stick injuries, injuries by other sharp objects and non-intact skin and mucous
membranes. This means that all specimen should be treated as if contaminated with
HIV, hepatitis B & C blood borne viruses and other infectious pathogens. To avoid
exposure to these pathogens precautions should be taken when handling possibly
contaminated specimen by including the use of PPEs, proper handling and disposal
of sharps, safe disposal of contaminated waste, safe handling of soiled linen,
adequate disinfection procedures and universal Hepatitis B vaccination of
laboratory personnel.
1.2 This SOP defines the procedures to be followed by a HCW in case of exposure to a
potentially infectious material in the laboratory.

2.0 SCOPE / RESPONSIBILITY:


2.1 This SOP applies to all laboratory personnel and other departments that use the
laboratories services.
2.2 It is the responsibility of the designated of the County Leads, Quality Assurance
and Quality Control (QC/QA) personnel, Laboratory Supervisors to ensure that the
current SOP is available to the laboratory personnel and the procedure is followed
as documented
3.0 SAFETY/RISK ASSESSMENT:
3.1 Wear personal protective equipment. Handle all samples as potential biohazards.
3.2 All contaminated wastes should be safely disposed off.
3.3 Surfaces contaminated with HIV infected products should be immediately
disinfected.

4.0 DEFINITIONS:
4.1 ART - Antiretroviral Therapy.
4.2 CSF - Cerebral Spinal Fluid.
4.3 HbsAg - Hepatitis B Surface Antigen.

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
MINISTRY OF HEALTH

SOP Title: : Post - Exposure Prophylaxis. Version 1


SOP No: LGEN. 0023

4.4 HBV - Hepatitis B Virus.


4.5 HCV - Hepatitis C Virus.
4.6 HIV - Human Immunodeficiency Virus.
4.7 MLTS - Medical Laboratory Technicians/ Technologists.
4.8 PEP - Post Exposure Prophylaxis.
4.9 PPE - Personal Protective Equipment.
4.10 QA - Quality Assurance.
4.11 SOP - Standard Operating Procedure.

5.0 SPECIMEN:
5.1 Not applicable.

6.0 EQUIPMENT/ MATERIALS/ REAGENTS:


6.1 Equipment.
6.1.1 Not applicable.
6.2 Materials.
6.2.1 Not applicable.
6.3 Reagents.
6.3.1 Not applicable.

7.0 METHODOLOGY:
7.1 Procedure for Post-exposure management in occupational exposure
7.1.1 Encourage bleeding from the site but do not scrub or cut the site, washing it
with soap and water
7.1.2 Do not apply caustic agents, including antiseptics or disinfectants to the
exposed area.
7.1.3 Inform the department manager of the exposure.
7.1.4 Record in incident/accident register. The following information must be
provided:
7.1.4.1 Date and time of exposure.
7.1.4.2 Exposure site (s).
7.1.4.3 Where and how the exposure occurred.
7.1.4.4 If a sharp object was involved, type and brand of device.

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
MINISTRY OF HEALTH

SOP Title: : Post - Exposure Prophylaxis. Version 1


SOP No: LGEN. 0023

7.1.4.5 Type and amount of fluid exposed to.


7.1.4.6 Severity of exposure (e.g. depth of sharp puncture, intact skin, eyes
7.1.4.7 Patient history (if HIV patient, check stage of disease, viral load,
history of ART etc.)
7.1.5 The department manager will refer the exposed staff for PEP to the medical
officer in-charge/designee who will evaluate the exposed staff on potential
infectious hazard based on;
7.1.5.1 Type an amount of body fluid/ tissue.
7.1.5.2 Type of exposure, whether needle stick injury, non-intact skin
exposure or mucous membrane exposure.
7.1.5.3 Status of the source and the infectious material - HIV, HbsAg and
HCV antibody tests.
7.1.5.4 HIV, HBV and HCV immune status of exposed laboratory staff.
7.1.5.5 Assess the potential risk of infection
7.1.5.6 Both the source and exposed person need to be counseled for HIV-
testing.
7.1.6 A known source should be tested for HIV; if the source person is not
willing to be tested, he/she should not be coerced into having the test.
7.1.7 Discarded sharps/needles should not be tested
7.1.8 The exposed person should not receive ARV drugs without being tested.
However, where immediate testing is not feasible, treatment should not be
delayed since HIV testing can be carried out the following day or soon
thereafter.
7.1.9 Counselling and support should be provided to the exposed and for those
who decline to be tested, they should be offered further appropriate support.
HIV test should be done at baseline, at 3 months and at 6 months for person
exposed.
7.1.10 Other baseline tests to be carried out where feasible include: FBC, LFT and
renal function.
7.2 Risk Assessment

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
MINISTRY OF HEALTH

SOP Title: : Post - Exposure Prophylaxis. Version 1


SOP No: LGEN. 0023

Low risk High risk.

Type of Intact skin. Mucus membrane/ non-intact skin,


exposure. Percutaneous injury.

Source. HIV-negative HIV status unknown; clinically


well/unwell.
Material. Saliva, tears, sweat, faeces, Semen, vaginal secretions, synovial,
urine, sputum, vomit pleural, pericardial,
peritoneal, amniotic fluids
Blood and bloody bodily fluids;
CSF; viral cultures.

7.3 Summary of medical management of medical PEP

Considerations Recommended Action


Eligibility  High risk exposure
 Exposure within 72 hours
 Exposed individual is not HIV infected
 Source individual HIV positive or of
unknown HIV status

Counselling and testing  Offer information on risks and benefits


the exposed individual  Verbal consent adequate
 Base-line HIV test in HIV exposed person
 Voluntary testing for both exposed and
source individuals

ARV agents for PEP  Adult: Preferred : TDF + 3TC + ATV/r


x 1 month
 Children: Preferred : ABC + 3TC + LPV/r

Time of initiation  As soon as possible after exposure, but no


later than after 72 hours

Duration of therapy  28 days

Dose of PEP  Same as indicated for ART; use dosing


wheel for children

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
MINISTRY OF HEALTH

SOP Title: : Post - Exposure Prophylaxis. Version 1


SOP No: LGEN. 0023

Follow-up  Follow up client at 7 days, 14 days and 28


days
 Follow-up HIV testing at 3 and 6 months
after exposure
 Pregnancy testing
 Hb (if AZT-containing regimen used for
PEP)
 Hepatitis B vaccination if not previously

 Adherence counselling, risk reduction,
Counselling trauma and mental


Other services for  STI prophylactic treatment to all
sexual assault  Emergency contraceptive for non-pregnant
women Tetanus Toxoid for any physical
injury of skin or mucous membranes
 Documentation of clinical evidence of
assault and collection
 of forensic evidence
 NOTE: Refer to National Guidelines on
management of Sexual Violence in Kenya
for comprehensive management

7.4 NOTE: Counseling on behavior change and risk reduction should be offered to
clients with repeated exposure risk

8.0 APPENDICES:
Not applicable.

9.0 REFERENCES:
9.1 Coast provincial general hospital ART Programme (March 1, 2005), SOP for
laboratory services, MSH/MoH.
9.2 Ministry of Health; National AIDS and STI Control Program (NASCOP).
Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV
Infection: A rapid advice, 2014
9.3 National public health laboratory services, strengthening laboratory services in
support of ART management (March, 2007), Laboratory standard operating
procedures, MOH publication, 1st edition.
NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
MINISTRY OF HEALTH

SOP Title: : Post - Exposure Prophylaxis. Version 1


SOP No: LGEN. 0023

10.0 DOCUMENT CHANGE HISTORY:


10.1 Version Table:
Version 1: Post - Exposure Prophylaxis. Dated: SOP No.: No. Pages:

Version 2: Dated: SOP No. No. Pages:

Version 3: Dated: SOP No.: No. Pages:

10.2 SOP Review Log


Date of Changes made. Name of reviewer. Signature.
review.

1.0 SOP AWARENESS LOG.

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
MINISTRY OF HEALTH

SOP Title: : Post - Exposure Prophylaxis. Version 1


SOP No: LGEN. 0023

I, the under named, have read and understand the contents of this SOP. I agree to
contact my supervisor/ designee if I have any query.

NO. DATE NAME SIGNATURE

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.
MINISTRY OF HEALTH

SOP Title: : Post - Exposure Prophylaxis. Version 1


SOP No: LGEN. 0023

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are not controlled.
Anyone using an uncontrolled copy is responsible for checking that they have the latest revision of the document prior to use.

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