Screening and testing biochemical and physiological parameters
| (a) | A pharmacy can offer services relating to screening and testing a patient's biochemical and physiological parameters. Pharmacists who are competent to do so may provide such screening and monitoring services. |
| (b) | Protocols must be established which specify records to be kept of test results and allow objective validation of the quality of both methods and equipment used for screening. Testing should be carried out at regular intervals within the protocol. |
| (c) | There must be effective communication with the patient's doctor and other relevant health care professionals. |
| (d) | Pharmacists and members of staff involved must have sufficient training to enable them to give appropriate and sound advice. |
| (e) | The specific service should be introduced to local members of the health professions (such as doctors, private registered nurses, etc.) and local clinics. The purpose of the service, for example that it is a screening and/or monitoring service, should be clearly emphasised. |
| (i) | Pharmacists are entitled to inform the public of the availability of screening and monitoring tests. |
| (ii) | According to the code of conduct of pharmacists, the advertisement must be factually correct, must not be misleading and must not bring the profession into disrepute. |
| (f) | Pharmacists may sell screening and monitoring tests to the public to perform at home. If the pharmacist performs the test, he/she is entitled to a professional fee based on an hourly tariff and the disposable items used (see services for which a pharmacy may levy a professional fee and guidelines for levying such a fee or fees). |
[Rule 2.13(f) substituted by Board Notice 193, GG 40522, dated 23 December 2016]
| 2.13.1 | Minimum standards on promotion of public health |
| 2.13.1.1 | Physical facilities |
The taking of samples, the performance of screening tests and blood pressure monitoring must be done in a private consultation area in the pharmacy. The consultation area must comply with the requirements described in 1.2.13 of Chapter 1 of this manual.
| 2.13.1.2 | Documentation and record keeping |
| (a) | The patient must give informed consent for the test to be performed. Consent may be either written or oral as appropriate. |
| (b) | Results must be provided to the patient in writing. Such written confirmation could also be used as a referral document, to be presented to the patient's medical practitioner or other health care practitioner. |
| (c) | Patients must be counselled regarding the test results and advice must be given concerning health risks and healthy lifestyles when appropriate. |
| (d) | All referral documents must be signed by the pharmacist as a confirmation that the test has been done by a professionally trained person. |
| (e) | The name of the pharmacy, as well as the name of the pharmacist who performed the test, must appear on all referral documents. |
| (f) | Should results be given telephonically, the pharmacist must ensure that the results are given to the appropriate person. This practice should, however, be avoided and results should be confirmed in writing. |
| (g) | The pharmacist must comply with any request from the patient that patient records and test results be made available to other health care professionals caring for the patient. |
| (h) | The following information must be kept for a period of at least three years: |
| (i) | a complete record of patient information; |
| (ii) | the kind of test used; |
| (iii) | the batch number of the testing material; |
| (iv) | the test results; and |
| (v) | a record of advice given to patients. |
| 2.13.1.3 | Professional and ethical aspects |
| (a) | Pharmacists must ensure that they have adequate training, knowledge and skills to perform screening tests and interpret and discuss the results thereof. |
| (b) | Confidentiality of patient information must be ensured throughout. |
| (c) | Patient information must only be disclosed with the consent of the patient or, in the case of a minor, with the consent of the parent or guardian, or where such information must be furnished to a person authorised by law to request it, unless such disclosure is in the interest of the patient. |
| (d) | The pharmacist must always act in the best interest of the patient. |
| (e) | Pharmacists must establish criteria for the referral of patients. It is preferable that these criteria are determined in consultation with local medical practitioners. |
| 2.13.2 | Minimum standards regarding testing |
| (a) | A person suffering from a communicable disease should not treat patients. |
| (b) | Disposable units must be used for biohazardous substances. Puncture-resistant containers must be used that are located as close as possible to the area of use. |
| (c) | Suitable procedures must be adopted for the disposal of waste material, bearing in mind the risks associated with materials contaminated with blood. |
| (d) | Needles or other sharp objects must not be recapped, bent or broken. |
| 2.13.2.1 | Minimum standards regarding test materials and instruments |
| (a) | Reliable tests and instruments must be used at all times. |
| (b) | Pharmacists performing the tests must be familiar with the instructions and requirements of individual products on the market, and must be aware of the limitations of the tests and realise that no test is 100% accurate. |
| (c) | The storage requirements of the test material must be noted and the product stored according to the manufacturer's instructions. |
| (d) | All unused material must be stored in the original containers. |
| (e) | If applicable, the drying material should not be removed from the original container. Lids must be replaced immediately after use. |
| (f) | Contamination of material and samples must be prevented. |
| (g) | The testing areas of reagent strips must not be touched. |
| (h) | Any discoloration or darkening of material can be an indication of deterioration of the reagent strips. |
| (i) | Expiry dates of material must be checked before use. |
| (j) | Instruments must be kept clean and in good working order and be calibrated regularly. |
| 2.13.2.2 | Minimum standards regarding the taking of samples |
| (a) | Correct methods for sample collection must be followed. |
| (b) | Samples must be collected in clean, dry containers not contaminated with cleansers. If manufacturers supply containers, these must be used. |
| (c) | Gloves must be worn in the following instances: |
| (i) | when touching blood and body fluids, mucous membranes or non-intact skin of patients; and |
| (ii) | when handling items or surfaces soiled with blood or body fluids. |
| (d) | Gloves must be changed after contact with each patient and hands washed. |
| (e) | Masks and protective eyewear or face shields must be worn during procedures that are likely to generate droplets of blood or body fluids. |
| (f) | Plastic aprons and gowns must be worn during procedures where blood or body fluid splashes are likely. |
| (g) | Hands and other skin surfaces must be washed immediately and thoroughly if they become contaminated with blood or body fluids. |
| (h) | All blood and body fluid specimens must be placed in sturdy containers with a secure lid and contamination of the outside of the container avoided. |
| 2.13.3 | Minimum standards for blood pressure monitoring services |
The following standards must be considered when a blood pressure monitoring service is established in a community pharmacy.
| (a) | Equipment needed for the performance of blood pressure monitoring is blood pressure monitors and stethoscopes and/or electronic monitors. |
| (b) | Equipment must be accurate, reliable, simple to use, easily cleaned and easily maintained. |
| (c) | To ensure ongoing accuracy and precision of determinations, a suitable quality control system of apparatus that are used, must be implemented and applied on a regular basis. |
| 2.13.3.2 | Procedure and interpretation of results |
The following aspects must be considered in blood pressure monitoring:
| (a) | The procedure must be explained to the patient, his/her permission obtained and the patient made to feel comfortable. |
| (b) | The person monitoring blood pressure must be thoroughly trained. When a monitor with a stethoscope is used instead of electronic equipment, eye, hand and ear coordination is essential to control the rate of inflation and deflation and to note the correct reading. |
| (c) | Blood pressure measurements of a specific patient should as far as possible be performed by the same person with the same instrument every time. |
| (d) | The patient should do no strenuous exercise, smoke, eat or drink coffee in the preceding 30 minutes. Blood pressure should not be taken immediately following defecation or urination. |
| (e) | The patient should be relaxed and sit in a comfortable chair in a pleasant and relaxing atmosphere for at least three minutes before the reading. |
| (f) | The patient's arm should rest on a soft surface. The arm from which the reading is to be taken should be on the same level as the heart in a horizontal position. This is especially important in the standing and seated positions. |
| (g) | The pulse rate should be determined at the same time as the blood pressure. |
| (h) | When the patient's blood pressure is being monitored at brief intervals, the same arm should be used. |
| (i) | Readings must be rounded off to the nearest whole number. This rounding off must be maintained consistently in order to prevent differences in interpretation. |
| (j) | Criteria for referral should be compiled in co-operation with local medical practitioners. |
| (k) | The diagnosis of hypertension is made on multiple sustained high blood pressure values taken on a few occasions (at least three occasions) preferably on different days or with intervals of 15 minutes. The patient must be calm and relaxed during the intervals. |
| (l) | The patient's age must be taken into account in the interpretation of blood pressure values. |
| (m) | The influence of certain drugs on the blood pressure of a patient must be taken into account. |
| (n) | When the blood pressure reading is noted, it should also be indicated whether the patient was seated, prone or standing up, as well as the extremity to which the apparatus was connected (left or right upper arm or thigh). Both systolic and diastolic pressure must be noted. Presence of arrhythmias and unusual circumstances such as anxiety must be noted. |
| 2.13.3.3 | Documentation and record keeping |
For regular monitoring of a patient's blood pressure it is essential that a complete patient profile system is kept. Apart from information that must be kept as described earlier, the following information must also be available:
| (a) | height and body mass; |
| (b) | medicines used and dosages for hypertension as well as other conditions; |
| (c) | family history (chronic diseases and problems); |
| (d) | presence of other risk factors such as smoking; |
| (e) | results of blood pressure measurements including the date on which the measurement was done, the position of the patient, the extremity to which the apparatus was connected and the pulse. |
| 2.13.4 | Minimum standards for the performance of peak flow tests |
The performance of peak flow tests in a pharmacy has a dual function. The first is to identify patients with reduced lung function, for referral to a medical practitioner, and secondly it provides an opportunity to advise asthma patients and other patients with respiratory diseases receiving medication on a chronic basis, about the control of their condition with the help of peak flow tests. The following standards must be used when such a service is provided in the pharmacy.
| (a) | Equipment needed for the rendering of the service are peak flow meters and standard charts with expected peak expiration flow values for men, women and children. |
| (b) | Equipment must be accurate, reliable, simple to use, easily cleaned and easily maintained. |
| (c) | Individual manuals of the various types of peak flow meters must be followed for the cleaning procedures. Instruments must be cleaned at least once a week. Peak flow meters must be checked regularly to ensure that they function correctly. A damaged instrument must never be used. |
| (d) | Pharmacists must implement a suitable quality assurance programme and apply it regularly to instruments to ensure the reliability of the determinations. |
| 2.13.4.2 | Procedure and interpretation of results |
The following aspects are of particular importance in the determination of peak expiration flow:
| (a) | The procedure must be explained to the patient, his/her permission obtained and the patient made to feel comfortable. |
| (b) | The peak expiration flow rate gives an objective indication of lung function. It is not an absolute value, but varies with the age, sex, height and medical condition of a person. It is important to observe the patient's age, sex and height in the interpretation of results. |
| (c) | Peak expiration flow rate is totally dependent on the correct technique being used. |
| (d) | The patient should preferably be in a standing position, otherwise he/she must sit upright. |
| (e) | Determinations should always be done with the patient in the same position and with the same peak flow meter. |
| (f) | There is a natural variation in the peak expiration flow rate with values in the morning generally lower than those taken in the evening. Determination should be done two or three times a day. On each occasion three determinations must be taken. The best value, date and time should be noted. The mean of the three determinations should not be noted. |
| (g) | Individual results of the patient must be compared to the expected average peak flow values (according to sex, age and height) on the nomograms that are supplied with the peak flow meter. Individual results can also be compared to the goal value determined by the patient's medical practitioner. The goal value of a patient must be re-evaluated annually to provide for the growth of children and possible changes in the disease of the patient. |
| (h) | On its own, peak flow determinations are not adequate to make a diagnosis. A diagnosis of asthma and other respiratory diseases involving airway obstruction must be confirmed through the determination of lung function with the help of a spirometer by a medical practitioner. |
| (i) | The patient's medical practitioner must be consulted in the case of reduced lung function, concerning the criteria for referral of the patient or adjustment of drug therapy. |
| 2.13.4.3 | Documentation and record keeping |
For regular monitoring of a patient's peak expiration flow it is essential that a complete patient profile system is kept. Apart from general information that must be kept, the following information must also be available:
| (a) | medicines used for asthma and/or other respiratory diseases and the dosages as well as medicines used for other conditions; |
| (b) | family history (chronic diseases and problems); |
| (c) | presence of other risk factors such as smoking; |
| (d) | goal peak flow value (determined by the patient's doctor); |
| (e) | results of peak flow measurements including the date, time and any abnormal symptoms experienced by the patient); and |
| (f) | results of peak flow measurements must be kept for at least three years. |
| 2.13.5 | Minimum standards for the performance of HIV tests |
Tests to detect HIV1 or HIV2 antibodies are now widely used in order to identify patients and to screen blood products. HIV infection is usually not noticed in the first few years after infection. Later signs and symptoms may suggest HIV infection or AIDS. The HIV antibody test is often the first and only definite evidence of HIV infection. The following standards must be applied when such a service is provided in the pharmacy.
| 2.13.5.1 | Physical facilities and equipment |
| (i) | Taking of samples and the performance of HIV antibody tests must be done in a private allocated area in the pharmacy. |
| (ii) | The consultation area must comply with the requirements laid down in section 1.2.13 of this manual. |
| (iii) | The following minimum furniture and fittings must be available in the consultation area: |
• desk with seating;
• working surface of impermeable washable material;
• wash hand basin with hot and cold running water;
• an instrument cabinet or trolley with an emergency tray;
• a filing cabinet for keeping records;
• a mirror;
• a scale;
• facilities for the disposal of biohazardous materials;
• access to a fridge (for storage of test materials).
Note: It is advisable that the fridge is situated in the consultation area, so that observers / bystanders cannot link the client with the removal of test material from the fridge.
If the pharmacy sends the samples to local pathology laboratories, the pathologists should be satisfied that the clinic facilities comply with the applicable standards and that the person performing the tests (pharmacist or nurse) is competent to collect samples and to counsel the patients.
| (b) | Reliable tests must be used. The most commonly used HIV antibody tests used by laboratories are the ELISA and the Western Blot tests. Some other rapid immunofiltration tests are currently used for the screening of HIV 1/2 antibodies (e.g. HIV-1/HIV-2 Rapid Assay, Sensy test). |
| (c) | The following equipment must be available: |
| (i) | a reliable HIV antibody test with its sample containers, diluents, etc. that is recommended by the MCC11 and purchased from a reputable company; |
| (ii) | requirements for the collecting of samples (e.g. blood tubes, etc.); |
| (iii) | disposable latex gloves; |
| (iv) | alcohol swabs or 70% alcohol solutions; |
| (vii) | disinfectants (especially disinfectants recommended for control of the AIDS virus e.g. 2% gluteraldehyde, 1% halocide, sodium hydrochloride, biodecyl 1%). |
| (d) | Pharmacists must be familiar with the instructions and requirements of individual products on the market. Instructions pertaining to one product will not necessarily be applicable to another. |
| (e) | Pharmacists must be aware of the limitations of tests used and realise that no test is 100% accurate. |
| (f) | Expiry dates of HIV antibody tests must be checked. |
| (g) | The manufacturer's storage requirements for the test material must be followed. |
| 2.13.5.2 | Collecting of samples |
| (a) | The correct method of collecting samples (serum, plasma, whole blood or saliva) has an important influence on the accuracy of the results. Personnel must be trained in the correct method of collecting samples. |
| (b) | A procedure to prevent interchange of blood samples must be implemented. Contamination of blood samples must be prevented. The samples must be clearly and correctly marked if they are sent to a laboratory. |
| (c) | Samples must be collected in clean, dry containers which are not contaminated. If manufacturers supply containers, these must be used. |
| (d) | Results are most accurate if samples are tested immediately. |
| (e) | Instructions for the execution of the different tests and the interpretation of results must be followed closely. |
| (f) | The person executing the test must be aware of his/her own physical limitations which could influence the interpretation of the results, for example, colour blindness. |
| (g) | Pharmacists must be familiar with the WHO guidelines for the prevention of HIV and hepatitis. The WHO has recommended that 'universal' precautions be taken with all patients, i.e. all patients be treated as if potentially infected and all body fluids and specimens from all patients be treated as potentially infectious. Infection control precautions existing in health care settings for Hepatitis B are sufficient to prevent transmission of HIV. |
| (h) | Recommendations for universal precautions are as follows: Wear gloves in the following situations: |
| (i) | when touching blood and body fluids, mucous membranes or non-intact skin of all patients; |
| (ii) | when handling items or surfaces soiled with blood or body fluids; |
| (iii) | when performing venipuncture or finger pricking procedures. |
Change gloves or wash your gloved hands after contact with each patient.
Wear masks and protective eyewear or a face shield during procedures that are likely to generate droplets of blood or body fluids.
Wear plastic aprons and gowns during procedures where blood or body fluid splashes are likely.
Wash your hands and other skin surfaces immediately and thoroughly if they become contaminated with blood or body fluids.
Wash your hands immediately after removing gloves.
Do not recap, bend or break needles or other sharp objects.
Place large-bore re-useable needles in a puncture-resistant container for transport to reprocessing areas.
Make mouthpieces, resuscitation bags and other ventilation devices available in areas where the need for resuscitation is likely.
Do not treat patients yourself or handle patient care equipment if you have exudative lesions or weeping dermatitis.
If a glove is torn, replace glove with a new one as soon as possible.
Place all blood and body fluid specimens in sturdy containers with a secure lid. Avoid contaminating the outside of the container.
Suitable procedures must be adopted for the disposal of waste material, bearing in mind the risks associated with materials contaminated with blood or other body fluids.
Note: Circumstances which require Post Exposure Prophylaxis (PEP)
| (a) | A pharmacist must seek counselling from other health care professionals if he/she incurs a needle stick injury during the performance of his/her duties. The HIV test must be done by another health care professional. |
| (b) | In a case of rape, the pharmacist must refer patients to a centre where post-exposure prophylaxis is available. Pharmacists in community pharmacy who are able to recover their cost on medicines for HIV post-exposure prophylaxis (PEP) may provide these medicines in accordance with the provisions of the Medicines Act and the guidelines of the National Department of Health. |
| 2.13.5.3 | Informed consent |
When a patient requests an HIV test, he/she must sign an informed consent form.
What is informed consent?
Informed consent is legal authorisation given to the pharmacist or other health care worker to proceed with the HIV testing.
Informed consent to HIV testing must be specific and explicit and means that the individual has been made aware of, and understands, the implications of the test.
Consent to HIV testing is not covered by the standard contractual agreement which is implied when a patient consults a doctor/pharmacist/nurse as the implications of a positive test may be extreme.
What does informed consent imply in the context of HIV testing?
Informed consent implies that the patient has received at least the essential amount of pre-test information and understands the following:
| (1) | The reason or purpose for which the test is being performed. |
| (2) | The potential advantages and disadvantages of having his/her HIV status determined. |
| (3) | The influence the result of the HIV test may have on his/her treatment. |
| (4) | The possible psycho-social impact of a positive test result. |
| (5) | The patient is free to decide against HIV testing even after having received pre-test counselling. |
| (6) | The testing procedure. |
| (7) | When the patient is ready for such counselling, post-test counselling is done one week after pre-test counselling and the blood test. The principle of informed consent implies that once the patient's test result is known (whether positive or negative), appropriate counselling must follow. Post-test counselling is an ongoing process. |
| (8) | Points 1-7 above must be conveyed clearly by a pharmacist to the patient in a manner that the patient will understand. |
Proxy consent
Proxy consent is consent by a person legally entitled to grant consent on behalf of another individual. A parent or guardian of a child below the age of consent to medical treatment may give proxy consent to HIV testing of a child.
| (a) | HIV testing needs to be done with much care and consideration. Due to the implications of receiving a positive result a person must always be counselled before testing in order to prepare the person as far as possible for the impact of the results (a pre-test counsel or interview). |
| (b) | Careful counselling must be provided to a person after the test (a post-test counsel or interview). |
| (c) | Counselling must be provided to persons whose results are negative to ensure that their results remain negative. |
| (d) | It is critical at the start, to establish a trusting relationship with the patient. |
| (e) | Total privacy must be assured during the consultation with the patient. |
Pre-Test Counselling
Pre-test counselling is counselling given to an individual before an HIV test, to make sure that the individual has sufficient information to make an informed decision about having an HIV test. Pre-test counselling must include discussions on:
| (a) | ensuring confidentiality; |
| (b) | the definition of HIV and AIDS; |
| (c) | transmission of HIV infection; |
| (d) | what an HIV test is, the purpose of the test; |
| (e) | the procedure and when to expect a result; |
| (f) | the meaning of a negative HIV test; |
| (g) | the concept of the window period; |
| (h) | the meaning of a positive result, including the practical implications such as medical treatment and care, sexual relations, psycho-social implications, work, etc.; |
| (i) | the personal and practical implications of performing the test; |
| (j) | assessment of personal risk of HIV infection; |
| (k) | safer sex and strategies to reduce risk; |
| (l) | possible reactions to negative and positive test results; |
| (m) | coping with a positive test result, including whom to tell and identifying needs and support services; |
| (n) | the social support available; |
| (o) | the return appointment; |
| (p) | the need to avoid blood/plasma/organ donation; |
| (q) | an opportunity for decision-making about taking the HIV test. |
Post-Test Counselling
Post-test counselling is the counselling provided when an individual receives his or her HIV test result. Post-test counselling involves one or more sessions (ideally at least two) and must include discussions on:
| (a) | Feedback and understanding of results; |
| (b) | if the result is negative: |
| (i) | Strategies for risk reduction; |
| (ii) | possibility of infection in the 'window' period; |
| (iii) | suggest retesting in three months' time; |
| (c) | If the result is positive: |
| (i) | Immediate emotional reaction and concerns; |
| (ii) | personal, family and social implications; |
| (iii) | difficulties a client may foresee and possible coping strategies; |
| (iv) | who the client wants to share the results with; |
| (v) | immediate needs and social support identification; |
| (vi) | follow-up supportive counselling; and |
| (vii) | follow-up medical care; |
| (viii) | possible routes of transmission; |
| (ix) | explain that the person is both infected and infectious; |
| (x) | the importance of notifying sexual partners; |
| (xi) | the likely progression of infection; |
| (xii) | the availability of care programmes, such as Aid for AIDS. |
| (d) | The counsellor must therefore ensure that the HIV positive patient is directed to an appropriate facility where he/she will receive ongoing counselling, support and care. If possible, sexual partners and/or families should also undergo counselling. |
| (e) | It is, therefore, essential to establish referral systems in the area, such as social workers, clinical psychologists, ministers of churches and other caregivers in the community. Meet with them to discuss this very important matter and establish whether they are knowledgeable about HIV and AIDS and whether they are prepared to collaborate with you. |
| (f) | Monthly statistics of all pre-test and ongoing counselling sessions as well as the number of tests completed during the month must be kept. |
| 2.13.5.5 | Interpretation of results |
| (a) | It usually takes up to 12 weeks for the pathology laboratory tests to be able to detect the presence of HIV antibodies. This means that an HIV antibody test may be negative very early after infection (before the 12-week period). This is called the 'window/' period. |
| (b) | If the HIV test is negative it usually means that the person has not been exposed or infected with the HIV virus (this is a 'true' negative test). It may be a false negative test. This means that the person has been exposed and infected with the HIV virus, but the test may have been done too soon after infection (1 -12 weeks) and he/she is still in the 'window' period. |
| (c) | If the HIV test is positive it means that the person is infected with HIV and can spread the virus to another person during sex or through his/her blood or during pregnancy, childbirth or breastfeeding. It does not mean that the person has AIDS or that the person will definitely develop AIDS. Many people who are HIV positive will, however, develop AIDS within 3-7 years after having been infected. |
Tests performed in pharmacies
Note: A doctor's signature is not required for an HIV test to be carried out.
| (a) | The wide availability of rapid tests enables pharmacists to contribute to the important measure of voluntary testing and counselling (VCT). Rapid tests have the advantage that the patient can receive the result almost immediately and does not have to return to the pharmacy later. A major disadvantage is that the short time interval between the performance of the test and the receipt of the result poses challenges for counselling. |
The following precautions and procedures must be borne in mind:
| (i) | Follow the test instructions exactly. |
| (ii) | Screening tests alone cannot be used to diagnose AIDS. |
| (iii) | If the test is positive, the patient must be referred to a laboratory to confirm the result with an ELISA and/or Western Blot. |
| (iv) | A negative test result at any time does not exclude the possibility of exposure to, or infection with HIV 1/2. |
| (v) | If the test result is negative and you suspect that the test has been done too early after a possible infection, advise the person to undergo a test again. This repetition of the test must be done at least 12 weeks after any likely infection. |
[Rule 2.13.5(5) (Note(a)) substituted by Board Notice 193, GG 40522, dated 23 December 2016]
| (b) | One way of deciding that the patient should be tested again or referred is by finding out whether the patient or his/her sexual partner has been at risk for acquiring HIV in the 12 weeks preceding the test. Ask if there has been any risky sexual activity in the 12 weeks before having been tested. Also make sure that you ask whether the patient's sexual partner has been at risk in the past 3 months. |
| (c) | Risky sexual activity may include having sex without a condom with a new partner, with more than one partner or with a sex worker (prostitute). Other risk factors that are important include sexually transmitted diseases in the past three months, sharing of needles or blood transfusions in the past three months. |
| 2.13.5.6 | Collecting and sending blood samples to a laboratory |
| (a) | If a pharmacist only collects the blood samples and sends them to a laboratory the following must be considered: |
| (i) | If a positive test is found with the ELISA, in low risk patients, the same test should be repeated on the same sample. |
| (ii) | If it is positive a second time, the recommendation is to confirm the ELISA with a test that is more specific, i.e. the Western Blot. |
| (iii) | Patients with repeatedly positive ELISA and confirming test (e.g. Western blot) results must be considered infected and contagious. |
| 2.13.5.7 | Documentation and record keeping |
| (a) | A patient must request in writing, i.e. give informed consent, that an HIV antibody test be performed. |
| (b) | Results must be provided to the patient in writing. Such written confirmation can also be used as a referral document, to be presented to the patient's doctor or local pathology clinic. |
| (c) | All referral documents must be signed by the pharmacist or other health care professional, as a confirmation that the test had been done by a professional person. |
| (d) | The name of the pharmacy, as well as the name of the pharmacist/health care professional who performed the test, must appear on all referral documents. |
| (e) | Results must not be given telephonically. |
| (f) | The following information must be kept for a period of at least one year: |
| (i) | name and address of patient, as well as ID number; |
| (ii) | date of birth of patient; |
| (iii) | brand of HIV antibody test used; |
| (iv) | lot number of the testing material; |
| (vi) | action taken by the pharmacist/health care professional; |
| (vii) | the name of the pharmacist/health care professional who performed the test. |
| (a) | It is advisable for the patient to make the final decision and choice whether to have the test or not. |
| (b) | Co-operation should be maintained with local pathology laboratories, local doctors and clinics. |
| (c) | A patient can only be tested with his/her informed consent. |
| (d) | Confidentiality of patient information must be ensured throughout. Patient information must only be disclosed with the consent of the patient, or in the case of a minor, with the consent of the parent or guardian, or where such information must be furnished to a person authorised by law to request it, unless such disclosure is in the interest of the patient. |
| (e) | In the provision of the service, the pharmacist must always act in the best interest of the patient. |
| (f) | Total privacy must be assured during the consultation with the patient. |
| (g) | All clients require and deserve the full attention of the person interviewing them. Rushed appointments, abbreviated counselling sessions and inadequate record keeping in no way serves the best interest of the patient. |
| (h) | [Rule 2.13.5(8)(h) deleted by Board Notice 193, GG 40522, dated 23 December 2016] |
| (i) | It is preferable that the infected person should tell his/her partners and family themselves. A counsellor can be present. |
| (a) | According to the 'ethical rules', pharmacists who want to perform HIV antibody testing have to ensure that they have adequate training, knowledge and skills to perform HIV antibody tests, interpret the results and to counsel patients being tested. |
| (b) | Every pharmacist who wants to do HIV antibody testing must be a trained HIV counsellor. Such training is provided for example by AIDS training and information centres. |
| (c) | Pharmacists involved in this service must be aware of— |
| (i) | the importance of a professional appearance; |
| (ii) | the importance of pre- and post-test counselling; |
| (iii) | confidentiality of patient information; |
| (iv) | the instructions and requirements of individual HIV antibody tests; |
| (v) | correct interpretation of results; |
| (vi) | the necessity of record keeping and referral of patients. |
| (d) | Pharmacists have to ensure that they have adequate knowledge about— |
| (i) | the immune system and the molecular biology of the virus; |
| (ii) | signs and symptoms of HIV and AIDS; |
| (iii) | opportunistic infections; |
| (iv) | major diseases associated with AIDS; |
| (vi) | transmission of the virus; |
| (viii) | ethical and legal aspects; |
| (ix) | the role of the pharmacist in the prevention of HIV and AIDS. |
| 2.13.5.10 | Advertising the service |
| (a) | The specific service should be introduced to local members of the health care professions (such as local pathology laboratories, doctors, local clinics, private registered nurses, etc.). |
| (b) | Pharmacists are entitled to inform the public about the availability of HIV antibody tests. The advertisement must be factually correct, must not be misleading and must not harm the dignity of the profession. |
| (c) | The following methods can be used: |
| (i) | oral information given to people visiting the pharmacy; |
| (ii) | enclosures in accounts; |
| (iii) | newsletters to regular clients; |
| (iv) | posters in the pharmacy, etc. |
| 2.13.6 | Minimum standards for cholesterol monitoring service |
Accuracy and precision of blood cholesterol measurement, which are critical for the classification and referral of screening participants, depend on appropriate quality control and staff training. As these services are professional services, any publicity should comply with the Code of Conduct and Minimum Standards for screening and monitoring services. Before undertaking testing, pharmacists should ensure they are adequately covered by insurance in respect of themselves, their staff and the patients who are being tested.
The following standards must be applied when a cholesterol monitoring service is established in a community pharmacy.
| 2.13.6.1 | Physical facilities |
| (a) | When taking samples, the performance of screening tests must be done in a private consultation area in the pharmacy. |
| (b) | The consultation area must comply with the requirements as described in 1.2.13. |
| (a) | Equipment must be accurate, reliable, simple to use, easily cleaned and easily maintained. |
| (b) | To ensure ongoing accuracy and precision of determinations, a suitable quality control system is used which must be implemented and applied on a regular basis. |
| (c) | A reliable method of testing should be used. |
| (d) | Equipment must be maintained in good order to ensure that performance is not impaired. |
| 2.13.6.3 | Procedure for carrying out the test |
| (a) | The service should be fully explained to the patient before any readings are taken. |
| (b) | Written consent must be sought and obtained before any test is carried out. |
| (c) | All procedures and arrangements should be in accordance with the requirements of the National Health Laboratory for clinical laboratories. |
| (d) | The pharmacist should wash his/her hands and then put on new, clean non-sterile examination gloves. |
| (e) | The site of puncture, for sample extraction from the patient's finger, should be wiped clean using a sterile alcohol swab. |
| (f) | Allow time for the alcohol to evaporate, otherwise this might interfere with the sample. |
| (g) | Care should be exercised when taking the sample. |
| (h) | Set the finger-pricking device at a suitable depth for thickness of skin to puncture. |
| (i) | Place the finger-pricking device on the cleaned puncture site and press activating button. |
| (j) | Time should be allowed for a large enough droplet of blood to develop. The pharmacist must inform the patient that care must be taken to ensure that the blood does not spill or drop. |
| (k) | The patient's droplet sample should be guided to the sample plate and the droplet placed on the blood stick. |
| (l) | The sample area should be saturated with the blood to ensure an accurate reading. |
| (m) | Record the Total Cholesterol and where possible the HDL reading immediately. |
| (n) | Where results are not within the desirable range, in addition to providing counselling and advising medical consultation where appropriate, pharmacists should provide suitable printed information leaflets where these are available. |
| (o) | Wipe and clean equipment with alcohol swabs. Dispose of waste from the procedures in front of patient. They can therefore be assured that the cleaning happens after each patient and can witness the procedure in order to achieve confidence in the service. |
| 2.13.6.4 | Interpretation of results |
| (a) | The result of the test should be provided in writing on a standard form. Where the results are not within a desired range, the patient's consent must be sought for this information to be sent to his/her GP. If a patient does not give permission for the pharmacist to contact his/her GP, he/she must be advised to seek medical advice, and must be supplied with the results in writing. |
| (b) | The form should be dated and signed by the pharmacist, with the name and address of the client provided. |
| (c) | At all stages, before and during and after the test, the patient should be kept fully informed about the process and implications of the test and be given opportunities to ask questions. |
| (d) | A single elevated cholesterol measurement does not establish the diagnosis of high blood cholesterol; two or more cholesterol measurements are needed before the diagnosis of high blood cholesterol. |
| (e) | Pharmacists are advised to be careful not to make any diagnostic decisions when undertaking cholesterol testing. |
| (f) | The patient's medical practitioner has the clinical responsibility for the diagnosis and subsequent clinical responsibility for the treatment of the patient. |
| 2.13.6.5 | Documentation and record keeping |
| (a) | The pharmacist must retain a written record of the result of the test, together with the following information for at least three years: |
| (ii) | batch number of the test material; and |
| (iii) | advice or referral given to the patient. |
| (b) | Such records must be stored safely to preserve confidentiality. |
The pharmacist must keep all information provided by the patient and the result of the test, confidential and only disclose information with the consent of the patient.
| (a) | Dressings, swabs and other contaminated wastes from treatment areas should be placed in a suitable clinical waste storage bag or bin with a suitable plastic liner at the point of generation. |
| (b) | Liner bags should be removed at least daily or when three-quarters full. They should be securely fastened with adhesive plastic tape before removal and deposited in a clinical waste storage bag — which should also be securely fastened. The waste should then be sent for incineration. |
| (c) | Syringes, needles and cartridges should be discarded intact and placed in a suitable 'sharps container', which when full should be sealed and placed into a chemical waste bag for storage prior to removal and disposal by incineration. |
| 2.13.6.8 | Counter infection measures |
All procedures and arrangements should be in accordance with the requirements of the National Health Laboratories for clinical laboratories. The main counter-infection measures, where applicable, should include:
| (a) | preventing puncture wounds, cuts and abrasions in the presence of blood and body fluids, and protecting existing wounds, skin lesions, conjunctivae and mucosal surfaces (aseptic hand washing techniques, use of an appropriate antiseptic etc., gloves, spillage procedures and cleaning procedures); |
| (b) | applying simple protective measures designed to avoid contamination of the person or clothing and using good basic hygienic practices, including regular hand washing; |
| (c) | controlling surface contamination by blood by ensuring containment and disinfection; |
| (d) | avoiding the use of sharps where possible but where their use is essential, exercising particular care in handling and disposal; and |
| (e) | disposing of clinical waste in accordance with Standard Operating Procedures. |
| 2.13.7 | Minimum standards for glucose monitoring |
Definition
Blood glucose monitoring is the measurement of glucose in the blood that can be done at any time on a portable machine. It can be used as a self-test for the diabetic.
Alternative names:
Glucose monitoring;
Random glucose;
Glucose — random; and
Serum glucose — random.
Why the test is performed
| (a) | This test is used as a screening test for blood glucose levels. |
| (b) | It may be used to screen for diabetes. |
| (c) | The test allows the diabetic to carefully monitor blood glucose levels to assure that they are within the normal range. |
| (d) | It may be used to monitor control in patients who have diabetes and to detect uncontrolled diabetic patients. |
| (e) | The individual can then respond quickly to high or low blood sugar levels with appropriate intervention. |
The following standards must be considered when a glucose monitoring service is established in a community pharmacy:
| 2.13.7.1 | Physical facilities |
| (a) | The taking of samples for the performance of screening tests must be done in a private consultation area in the pharmacy. |
| (b) | The consultation area must comply with the requirements as described in 1.2.13. |
The following aspects must be considered in glucose monitoring tests:
| (a) | equipment must be accurate, reliable, simple to use, easily cleaned and easily maintained; |
| (b) | accuracy and precision of blood glucose measurements, which are critical for the classification and referral of screening participants, depends on appropriate quality control and staff training; |
| (c) | to ensure ongoing accuracy and precision of determinations, a suitable quality control system is used which must be implemented and applied on a regular basis; |
| (d) | the use of calibration and control solutions by the pharmacist shall assure accuracy of results; |
| (e) | the user should know whether the instrument is calibrated to whole blood or plasma glucose; and |
| (f) | equipment must be maintained in good order to ensure that performance is not impaired. |
| 2.13.7.3 | Performance of the test |
| (a) | The service should be fully explained to the patient before any readings are taken. |
| (b) | Written consent from the patient must be sought and obtained before any test is carried out. |
| (c) | It is important to have all test items within reach before starting the test. |
| (d) | All procedures and arrangements should be in accordance with the requirements of the National Health Laboratory for clinical laboratories. |
| (e) | The pharmacist should wash his/her hands and then put on non-sterile examination gloves. |
| (f) | The site of puncture for sample extraction from the patient's finger should be wiped clean using a sterile alcohol swab. |
| (g) | Allow time for the alcohol to evaporate, otherwise it might interfere with the sample. |
| (h) | Care should be exercised when taking the sample and correct procedure must be followed or the results will not be accurate. |
| (i) | Set the finger-pricking device at a suitable depth for thickness of skin to puncture. |
| (j) | Place the finger-pricking device on clean sample area and press activating button. |
| (k) | Time should be allowed for a large enough droplet of blood to develop. The operator must inform the patient that care must be taken to ensure that the blood does not spill or drop. |
| (l) | The patient's blood droplet should be guided to a reagent strip, which uses a chemical substance to react to the amount of glucose in the blood. |
| (m) | When using enzyme impregnated strips for glucose measurement, it is imperative that the strips are properly stored in the screw cap airtight container provided until use, to ensure for maximum shelf life. |
| (n) | The reagent strip should be saturated with the blood to ensure an accurate reading. |
| (o) | The meter then reads the strip and displays the results as a number on a digital display. |
| (p) | Newer monitors can use blood from other areas of the body besides the fingers, reducing discomfort. |
| (q) | Record the glucose reading immediately. |
| (r) | Patients must be provided with the results in a written form. Where the results are not within a desired range, the patient's consent must be sought for this information to be sent to his/her GP. If a patient does not give permission for the pharmacist to contact his/her GP, he/she must be advised to seek medical advice, and must be supplied with the results in writing. |
| (s) | Where results are not within the desirable range, in addition to providing counselling and advising medical consultation where appropriate, pharmacists should provide suitable printed information leaflets where these are available. |
| (t) | Before undertaking testing, pharmacists should ensure they are adequately covered by insurance in respect of themselves, their staff and the patients who are being tested. |
| (u) | Dispose of waste from the procedures in front of the patient who can therefore be assured that the cleaning happens after each patient and can witness the procedure in order to achieve confidence in the service. |
| 2.13.7.4 | Interpretation of results |
| (a) | The result of the test should be provided in writing on a standard form. |
| (b) | The form should be dated and indicate the name and address of the client. |
| (c) | At all stages, before and during and after the test, the patient should be kept fully informed about the process and implications of the test and be provided with the opportunity to ask questions. |
| (d) | A single elevated glucose measurement does not establish the diagnosis of high blood glucose. Two or more glucose measurements are needed before the diagnosis of high blood glucose. |
| (e) | Pharmacists may not make any diagnostic decisions when undertaking glucose testing. |
| (f) | Pharmacists must take into account any food that the patient may have eaten prior to the test when interpreting the results. |
| (g) | The medical practitioner has the clinical responsibility for the diagnosis and subsequent clinical responsibility for the treatment of the patient. |
| 2.13.7.5 | Documentation and record keeping |
The pharmacist must retain a written record of the result of the test, together with information and the consent form provided by the client as well as the type of test and batch number of the test materials, for at least 3 years. Such records must be stored safely to preserve confidentiality.
The pharmacist must keep all information provided by the patient and the result of the test confidential and only disclose information with the consent of the patient.
| 2.13.8 | Minimum standards for pregnancy testing service |
The following standards must be considered when a service offering performance of pregnancy tests is established in a community pharmacy.
| 2.13.8.1 | Physical facilities |
| (a) | The performance of pregnancy tests must take place in a private consultation area in the pharmacy. |
| (b) | A clean toilet facility attached to the pharmacy is a necessity for the production of a urine sample. |
| (c) | The consultation area must comply with the requirements as described in 1.2.13. |
| (d) | A reliable method of testing must be used. |
| 2.13.8.2 | Procedure, interpretation and provision of results |
The following aspects must be considered in pregnancy testing:
| (a) | the procedure must be explained to the patient, her permission obtained and the patient made to feel at ease; |
| (b) | a signed and dated confirmation of the request for the test should be obtained; |
| (c) | the form on which confirmation is obtained should state the limits of accuracy of the test; |
| (d) | all questions relating to the test must be asked by the pharmacist and the answers recorded in writing; |
| (e) | a Standard Operating Procedure, to be available in the pharmacy for inspection, must be devised and followed to ensure that no confusion occurs between samples; |
| (f) | care must be taken to prevent contamination, which can result from the handling of samples of urine; |
| (g) | persons carrying out tests should wash their hands before leaving the consultation area; |
| (h) | any cuts and grazes on hands or on exposed parts of the body must be covered with waterproof dressings; |
| (i) | the result of the test must be provided in writing on a standard form; |
| (j) | the form must be dated, signed by the pharmacist, and bear the name and address of the client; |
| (k) | the result should be given as positive or negative with an explanation of such terms and the limits of accuracy of the test, e.g. 'The specimen provided has been tested for urinary gonadotrophin and has been found to be: Positive/Negative. A positive result indicates a probable pregnancy'; |
| (l) | at the request of the client, a copy of the form should be sent to her medical practitioner; and |
| (m) | notwithstanding the result of the test, the client should be strongly advised to consult her medical practitioner or reproductive health service. |
| 2.13.8.3 | Documentation and record keeping |
The pharmacist must retain a written record of the result of the test, together with information and the consent form provided by the client as well as the type of test and batch number of the test materials, for at least 3 years. Such records must be stored safely to preserve confidentiality.
The pharmacist must keep all information provided by the patient and the result of the test confidential and only disclose information with the consent of the patient.
| 2.13.9 | Minimum standard for urine analysis |
Urine analysis can be used to detect and measure the level of a variety of substances in the urine, including leucocytes, nitrite, urobilinogen, protein, pH, blood, specific gravity, ketones, bilirubin and glucose. These tests use a thin strip of plastic (dipstick) impregnated with chemicals that react with substances in the urine and change colour. For confirmation, the test may need to be repeated with more sophisticated and accurate laboratory analysis of the urine, in which case the patient should be referred to a medical practitioner. The following standards must be considered when a service offering performance of urine analysis is established in a community pharmacy.
| 2.13.9.1 | Physical facilities |
| (a) | A clean toilet facility attached to the pharmacy is essential. |
| (b) | Screening tests must be performed in a private consultation area in the pharmacy. |
| (c) | The consultation area must comply with the requirements as described in 1.2.13. |
The urine sample must be collected in a suitable clean container, which should be supplied to the patient.
| 2.13.9.3 | Procedure for carrying out the test |
The following aspects must be considered in urine testing:
| (a) | the procedure must be explained to the patient, his/her permission obtained and the patient made to feel at ease; |
| (b) | a signed and dated confirmation of the request for the test must be obtained; |
| (c) | the form on which confirmation is obtained should state the limits of accuracy of the test; |
| (d) | all questions that the patient or the patient's caregiver may have relating to the test must be answered by the pharmacist and the answers recorded in writing; and |
| (e) | a Standard Operating Procedure, to be available in the pharmacy for inspection, must be devised and followed to ensure that no confusion occurs between samples. |
| 2.13.9.4 | Obtaining a clean-catch urine sample |
The following information and procedure for obtaining a clean catch urine sample must be explained to the patient or the patient's caregiver, the:
| (a) | procedure is quite simple; there is usually no fluid or food restriction before the test; |
| (b) | head of a man's penis or the opening of a woman's urethra is cleansed, usually with a small pad that contains an antiseptic substance; |
| (c) | first few drops of urine are allowed to flow into the toilet, washing out the urethra; |
| (d) | patient must collect the mid-stream urine in a sterile container; and |
| (e) | last few drops of urine are allowed to flow into the toilet. |
| 2.13.9.5 | Storage and testing of samples |
| (a) | Contamination of testing material and samples must be prevented. |
| (b) | Urine samples must be stored at room temperature and tested within 4 hours of collection. |
| (c) | Urine must not be exposed to direct sunlight as this may result in the oxidation of bilirubin and urobilinogen. |
| (d) | The testing areas of reagent strips must not be touched by hand or come into contact with the working surfaces or other materials. |
| (e) | Expiry dates of material must be checked before use. |
| (f) | Remove one strip at a time and replace the lid immediately. |
| (g) | Strips must be checked for any discolouration or darkening of material which could be an indication of deterioration of the reagent strips. |
| (h) | Dip the test strip into fresh urine for approximately 2 seconds. |
| (i) | Drain excess urine on the rim of the container in which the urine was collected. Remove excess urine by briefly blotting the side of the strip on absorbent tissue. |
| (j) | After 30–60 seconds (60–120 seconds in the case of the leucocytes test patch) compare the test strip with the colour scale or the colour grades on the label. |
| (k) | NB: Colourations which appear only along the edges of the test patches, or develop after more than two minutes, do not have any diagnostic significance. |
| (l) | Persons carrying out tests should wash their hands before leaving the consultation area. |
| (m) | Any cuts and grazes on hands or on exposed parts of the body must be covered with waterproof dressings. |
| 2.13.9.6 | Interpretation of results |
| (a) | The result of the test should be provided to the patient or his/her caregiver in writing on a standard form, which includes the date and the name and address of the patient and which is signed by the pharmacist. |
| (b) | Where the results are not within the desired range, the patient's consent must be sought for this information to be sent to his/her medical practitioner. If a patient does not give permission for the pharmacist to contact his/her GP, he/she must be advised to seek medical advice, and must be supplied with the results in writing. |
| (c) | Abnormal findings indicate certain problems e.g.: |
Protein: Protein in the urine (proteinuria) can usually be detected quickly by using a dipstick. Protein may appear constantly or only intermittently in the urine, depending on the cause. Proteinuria is usually a sign of kidney disorders. Proteinuria may be benign or pathological.
Abnormal protein values may be indicative of:
Benign proteinuria
Pathological proteinuria
External
Renal
Glucose: Glucose in the urine (glucosuria) can be detected accurately by dipstick. The most common cause of glucose in the urine is diabetes mellitus.
Abnormal glucose values may be indicative of:
| • | renal glycosuria during pregnancy |
| • | excessive consumption of carbohydrates |
Ketones: Ketones in the urine (ketonuria) can be detected by dipstick. Ketones are formed when the body breaks down fats, rather than glucose which are used to produce energy. Ketones are harmful to the body if allowed to accumulate.
Abnormal ketones values may be indicative of:
| • | insufficient food intake |
| • | severe fever due to infection |
Blood: Blood in the urine (haematuria) is detectable by dipstick and confirmed by microscopic examination of the urine, and other laboratory tests. Sometimes there is enough blood in the urine to be visible, making the urine appear red or brown. The patient must be referred to a medical practitioner when blood cells or haemoglobin are detected in urine, as it is of pathological significance.
Abnormal blood/haemoglobin values may be indicative of:
Haematuria (blood in urine)
| • | kidney and bladder calculi |
| • | damage to kidney or urinary tract |
Haemaglobinuria (haemoglobin in urine)
| • | breakdown of red blood cells |
Myoglobinuria
Nitrites: Nitrites in the urine (nitrituria) are also detectable by dipstick. High nitrite levels indicate urinary tract infection.
Abnormal nitrite values may be indicative of:
Bacterial infection
Leukocyte Esterase: Leukocyte esterase (an enzyme found in certain white blood cells) in the urine can be detected by dipstick. Leukocyte esterase is a sign of inflammation, which is most commonly caused by a urinary tract infection.
Abnormal leukocytes values may be indicative of:
pH levels in urine: The acidity or alkalinity of urine is measured by dipstick. Certain foods and metabolic disorders may change the acidity of urine.
Abnormal pH values may be indicative of:
Persistent alkaline urine (pH 7–8)
| • | suggests urinary tract infection |
| • | pyloric stenosis/obstruction |
Persistent acid urine (pH 5–7)
| • | predisposition to uric acid calculi (kidney stones) |
Concentration: The concentration of urine (also called the osmolality or specific gravity) may be important in diagnosing abnormal kidney function. The kidneys lose their capacity to concentrate urine at an early stage of a disorder that leads to kidney failure. In one special test, a person drinks no water or other fluids for 12 to 14 hours; in another, a person receives an injection of antidiuretic hormone. Afterward, urine concentration is measured. Normally, either test should make the urine highly concentrated. However, in certain kidney disorders (such as nephrogenic diabetes insipidus), the urine cannot be concentrated even though other kidney functions are normal.
Abnormal specific gravity values may be indicative of:
Reduced specific gravity
Raised specific gravity
| • | congestive cardiac-failure |
Constant specific gravity
Urobilinogen: When abnormal values of urobilinogen are found during a urine test, further investigation is required to ascertain patient's health status. In the intestines bacteria form urobilinogen from bilirubin. This is then absorbed and passes to the liver and urine.
Abnormal urobilinogen values may be indicative of:
Increased values
| • | overburdening of the liver |
| • | excessive RBC (red blood cells) breakdown |
| • | increased urobilinogen production |
| • | re-absorption — a large hematoma |
| • | restricted liver function |
Low values
| • | failure of bile production |
| • | obstruction of bile passage |
Bilirubin: Bilirubin levels in urine is a result of haemoglobin breakdown. In the liver, bilirubin is conjugated to an acid to make conjugated bilirubin. Conjugated bilirubin is water soluble and can therefore be excreted in urine.
Abnormal bilirubin values may be indicative of:
Pre-hepatic condition
| • | excessive breakdown of RBC |
Hepatic condition
| • | obstruction of biliary duct, |
Post-hepatic condition
| • | biliary tree obstruction. |
| 2.13.9.7 | Documentation and record keeping |
| (a) | The pharmacist must retain a written record of the result of the test, together with information provided by the patient, the type of test used and the batch number of the test material, for at least one year. |
| (b) | Such records must be stored safely to preserve confidentiality. |
The pharmacist must keep all information provided by the patient and the result of the test, confidential and only disclose information with the consent of the patient.
___________________________________________________
11 Please note that at present the MCC does not register HIV tests, but recommends that these tests must be purchased from reputable companies. It is recommended that it be ascertained whether the test is registered in the country of origin.
