8.1. Setting policies and standard operating procedures
As explained in Chapter 1, these best practice guidelines for phlebotomy extend the scope of the two WHO/SIGN documents on related topics that are currently available (29, 30). At the heart of the document are three principles.
Standards of safe practice globally should be governed by evidence-based principles.
Each phlebotomy service should, within its capacity, ultimately strive to achieve best practices.
Health workers should be protected and allowed to work in a safe environment, armed with knowledge that reduces harm to themselves, patients and the community.
This chapter provides recommendations (in boxes) and gives further information for each recommendation (text below the boxes).
8.2. Procurement
Recommendation on procurement (in conjunction with the WHO guiding principle for injection device security (71)
Procurement agencies must ensure that all health-care facilities have sufficient supplies of phlebotomy and personal protective equipment. Such equipment must meet at least the minimum standards of sterility, quality and safety to prevent complications related to unsafe practices.
To prevent the complications related to unsafe practices discussed in Parts I and II of this document, equipment (including materials for hand hygiene) and personal protective clothing must be routinely available in sufficient quantities. Items needed include:
personal protective equipment;
safe blood-sampling equipment of high quality, based on a cost–effectiveness analysis of the country's needs and finances;
antiseptics.
All items to be used on more than one patient should be designed so that they can be cleaned and disinfected. Such items include laboratory transport boxes or trays, tourniquets, evacuated tube holders, scissors and so on. Also, it is best to buy high-quality items even if they are more expensive. Trying to save money by purchasing cheap items that are of poor quality can be more costly in the long run; for example, if items have to be replaced more frequently.
Governments and procurement agencies should work to ensure that appropriate products are available in the country, by:
providing detailed technical specifications to companies wishing to enter the market – such specifications should include detailed minimum standards acceptable for safety, quality and usability;
working with manufactures to communicate defined needs to improve products;
working with national or international regulatory authorities to test products before importation, to ensure they meet their stated claims and are more effective than cheaper products available on the market;
working together to ensure fair, transparent competition and input of end users during product selection;
conducting post-marketing surveillance to track defects and adverse events associated with products.
Facilities that cannot afford the supplies needed to minimize risk to staff and patients, or supplies of the quality necessary for valid and reliable laboratory test results, should reassess whether they should offer phlebotomy or the related laboratory services.
8.2.1. Blood-sampling equipment
Recommendation on blood-sampling equipment (Annex C)
Safety-engineered evacuated tube systems or winged needle sets are safer than a hypodermic needle and syringe, but all are effective for blood sampling. Safety features (e.g. needle covers, needleless transfer systems or adaptors, and retractable lancets) can further reduce the risks associated with manual recapping, needle removal, disassembly and transfer of blood from syringes to tubes.
A needle and syringe is the most common tool for withdrawing large quantities of blood.
A sterile single-use needle and syringe should be used for each patient, and should be placed, as a single unit, into a sharps container immediately after use.
Safety-engineered equipment offers better protection to the health worker, but should be appropriate for the specific task. Some devices designed to prevent reuse (e.g. auto-disable syringes) are not appropriate for phlebotomy. Safety devices are more expensive, so if resources are limited, their use may need to be restricted to procedures associated with the greatest rates or risk of sharps injury.
Capillary punctures should be performed using a sterile device – preferably with safety features that automatically retract the lancet – to help prevent both reuse and sharps injuries.
8.2.2. Protection
Recommendation on personal protection
Health workers should wear well-fitting, non-sterile gloves when taking blood; they should also carry out hand hygiene before and after each patient procedure, before putting on and after removing gloves.
Clean, non-sterile examination gloves in multiple sizes should be available for personnel who carry out phlebotomy. It is recommended that:
well-fitting gloves are worn for each procedure, irrespective of the site of blood sampling or the status of the patient; these gloves can be latex or latex-free, and should be non-sterile (i.e. examination gloves);
the gloves are changed between patients;
masks, visors and eye protection may also be needed if additional blood exposure is anticipated; for example, during arterial blood sampling.
8.3. Phlebotomy training
Recommendation on phlebotomy training (Annex E)
All health workers undertaking phlebotomy must be trained in infection prevention and control procedures. Staff should receive training and demonstrate proficiency on the specific methods that they will use on the job; for example, adult and paediatric sampling; and venous, arterial and capillary blood sampling.
Regular in-service training and supportive supervision should be provided.
The training programme should provide theoretical and practical knowledge in blood sampling and blood drawing (
31).
A certificate of competence should be issued upon successful demonstration of phlebotomy after completion of the training programme.
8.4. Safe waste and sharps disposal
Recommendation on safe disposal of sharps (72)
The blood-sampling device – a needle and syringe, evacuated needle and tube holder, or winged butterfly – should be disposed of immediately after use as a single unit. It should be placed in a puncture-proof, leak-proof, closable sharps container that is clearly visible and is placed within arm's reach of the health worker.
The safe disposal of sharps is one of the major challenges, particularly in poorly resourced countries.
Shortage of sharps containers can result in increases in needle-stick injuries due to:
- –
needle recapping;
- –
decanting of used sharps containers;
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recycling of containers;
- –
overfilling of sharps containers.
Another issue is that staff may separate a needle and syringe as a cost-saving exercise and discard the two parts in different waste systems.
The immediate discard of used sharps into a puncture-resistant sharps container that can be closed is an essential part of managing waste without needle-stick injuries (
73).
8.5. Prevention and management of incidents and adverse events
Recommendation on infection control (Annex B)
Infection control procedures that help to prevent health-care associated infections include:
hand hygiene;
glove use;
skin antisepsis;
sterile, single-use blood-sampling devices;
sharps containers;
disinfection of surfaces and chairs;
cleaning and disinfection of tourniquets;
transportation of laboratory samples in labelled, washable containers.
Annex B summarizes the recommendations for best infection control practices in phlebotomy. The points listed below contribute to infection control.
The workplace should be clean, tidy and uncluttered. There should be no sign of blood contamination on the chairs, counters or walls. The working surface should be visibly clean.
Hand hygiene (hand washing or use of an alcohol rub) should be carried out before well-fitting, non-sterile gloves are put on and after they are removed (
45).
Only sterile, single-use blood-sampling devices should be used to take blood.
Skin at the venepuncture site should be disinfected, taking into consideration the type of specimen, the age and the allergy history of the patient (
40–
42).
Once the procedure has been completed and the blood sample or samples have been put into the laboratory sampling tubes, the used devices should be discarded immediately into a sharps container.
Specimens should be transported in containers that help to prevent breakage or spillage of blood.
8.5.1. Patent related
Recommendation on increasing patient confidence (Annex F)
Health-care facilities should provide a patient information leaflet or poster explaining the procedure in simple terms, to increase patient confidence.
Patient information (leaflets or posters) is recommended. In a busy clinic, there may not be time to explain the procedure to the patient, or the reason for the blood sample being taken.
Information should be provided to a fully conscious patient in such a way that the person can make an informed decision. Being well informed also helps the patient to relax and may reduce discomfort during the procedure.
If the patient is mentally incapacitated (e.g. through mental illness, organic impairment, or traumatic or drug-associated loss of consciousness), essential blood sampling may be carried out without permission, in accordance with the institutional or national policy. However, the status of the patient should be clearly documented in the patient's clinical notes.
If the patient is unconscious or unable to give informed consent, the next of kin or legal guardian (which can be a court of law) can give permission for a blood sample to be taken.
When carrying out blood sampling on a minor, verbal or written permission from the parent or legal guardian, or a court of law may be necessary for medicolegal reasons.
8.5.2. Health-worker related
Recommendation on health worker and patient safety policies
A post-exposure prophylaxis protocol must be available in all health-care facilities and phlebotomy areas, providing clear instructions to follow in case of accidental exposure to blood or body fluids.
Should an exposure occur, health workers should be aware of the policy on PEP. Ideally, this policy should offer support for exposure to HIV, HBV and HCV (
27).
Worksites should have clear notices giving the point of contact (both during the day and at night) where staff may receive assistance, support and care, including PEP and the benefits of prompt reporting for preventing infection. This applies to potentially exposed patients as well.
Occupational injuries should be reported in a system that allows medical management and tracking of exposed individuals, but also allows anonymous analysis of incidents, to identify factors that can be modified to prevent accidents. Some facilities supplement requests for medical management with periodic anonymous surveys to improve reporting of exposures and near misses.
The benefits of PEP for HIV may be greatest if it is started as soon as possible; certainly, it should be started no later than 72 hours after exposure (
27). Both the source patient and the exposed individual should undergo rapid testing to avoid unnecessary treatment. Based on the test result or if the risk assessment requires it, antiretroviral therapy prophylaxis should be proposed as soon as possible; ideally within the first hours, and certainly no later than 72 hours after the exposure.
Hepatitis B immunization should be offered to all those working in health-care facilities, and especially to phlebotomists. One to two months after completing the three-dose series, the health worker should be tested to verify seroprotection (i.e. a concentration of antibodies to hepatitis B surface antigen of at least 10 milli-international units per millilitre [10 mIU/ml]). This is important because follow-up – including repeat serology testing after exposure to a patient positive for hepatitis B surface antigen – is unnecessary if the exposed person was known to have responded to the vaccine. Titres will decrease over time, even in those who are seroprotected, but the vaccinated person remains protected. In case of exposure, national guidelines on PEP for HBV exposure should be consulted. If none are available, detailed instructions on the use of hepatitis B immune serum globulin (HBIG) and immunization against HBV are available from WHO (
27).
A fourth dose of hepatitis B vaccine should be offered to those who have completed their immunization but were tested 1–2 months after completing the vaccination and had a hepatitis B surface antibody titre below 10 mIU/ml. If fewer than three doses of hepatitis B immunization have been given, a course of hepatitis B immunization should be provided or completed.
There is no recommended PEP for exposure to HCV. If feasible, testing of the source patient and health worker may be helpful to ensure workers compensation in the case that occupationally acquired infection is demonstrated. Research on PEP for HCV is ongoing to determine whether a regimen involving peginterfeon alfa-2b is effective. However, at least one recent trial failed because none of the 213 workers exposed to HCV developed infection, whether they received PEP or not (
74).
8.5.3. Risk assessment and risk reduction strategies
There is a risk to both patients (or blood donors) and health workers if the phlebotomist is not well informed of the patient's risks. A short clinical history from the patient is essential.
Risk can be reduced by following best practices in infection prevention and control, after obtaining informed consent from the patient and blood donors ().
Summary of risks and risk-reduction strategies.
