SAQA

All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.

SOUTH AFRICAN QUALIFICATIONS AUTHORITY

REGISTERED QUALIFICATION THAT HAS PASSED THE END DATE:

National Higher Certificate: Biomedical Technology

SAQA QUAL ID	QUALIFICATION TITLE
1925	National Higher Certificate: Biomedical Technology
ORIGINATOR
Committee of Technikon Principals
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY			NQF SUB-FRAMEWORK
CHE - Council on Higher Education			HEQSF - Higher Education Qualifications Sub-framework
QUALIFICATION TYPE	FIELD		SUBFIELD
National Higher Certificate	Field 09 - Health Sciences and Social Services		Promotive Health and Developmental Services
ABET BAND	MINIMUM CREDITS	PRE-2009 NQF LEVEL	NQF LEVEL	QUAL CLASS
Undefined	240	Level 5	Level TBA: Pre-2009 was L5	Regular-Provider-ELOAC
REGISTRATION STATUS		SAQA DECISION NUMBER	REGISTRATION START DATE	REGISTRATION END DATE
Passed the End Date - Status was "Registered"		SAQA 1536/01	2003-07-01	2006-06-30
LAST DATE FOR ENROLMENT		LAST DATE FOR ACHIEVEMENT
2007-06-30		2010-06-30

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.

This qualification does not replace any other qualification and is not replaced by any other qualification.

PURPOSE AND RATIONALE OF THE QUALIFICATION

The qualifying learner will be able to apply principles and techniques used in a limited range of analyses of biological specimens and or other substances in clinical diagnostic laboratories and related fields under supervision in compliance with statutory requirements for ethics, safety, quality assurance. The qualified person will be able to register with the Health Professions Council of South Africa (HPCSA).

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING

FET certificate at NQF level 4, with English language, Mathematics, Science and Biology or equivalent at NQF 4.

RECOGNISE PREVIOUS LEARNING?

QUALIFICATION RULES

The qualification will be awarded to a learner who has provided evidence to the satisfaction of the assessors that the stated competence of the qualification, as detailed in the specified outcomes, has been achieved, either through education and training in a provider's learning programme, or through experience that complies with the stated specified outcomes.

EXIT LEVEL OUTCOMES

1. * Perform a predetermined range of analytical tests on body fluids, tissues and other substances in the place of study, workplace, or both.

Footnote : Underpinned by ethics, safety and communication
* The learners are competent to** SOP - Standard Operating Procedures

2. * Confirm and validate results through application of a knowledge of principles, techniques, instruments, physiological and pathophysiological conditions in the place of study, workplace or both.

Footnote : Underpinned by ethics, safety and communication
* The learners are competent to

3. * Perform and monitor Quality Control procedures within pre-determined limits.

Footnote : Underpinned by ethics, safety and communication
* The learners are competent to
4. * Manage time and resources efficiently and effectively.

5. * Demonstrate professional conduct in compliance with ethical principles.

Footnote : Underpinned by ethics, safety and communication
* The learners are competent to

6. * Apply laboratory safety procedures and demonstrate a knowledge of the relevant legislation.

Footnote: Underpinned by ethics, safety and communication
* The learners are competent to** OHS Act - Occupational Health and Safety Act

7. * Communicate effectively with patients, laboratory personnel, other health care professionals and with the public.

SPECIFIED OUTCOME
1.1 * Prepare and store laboratory reagents, stains and media.(C) (10 Credits) (NQF 5)
1.2 * Use and maintain lab equipment.(C) (7,5 Credits) (NQF 5)
1.3 * Collect and assess suitability of specimens.(C) (5 Credits) (NQF 5)
1.4 * Store or transport samples using appropriate methods.(C) (5 Credits) (NQF 5)
Footnote: Underpinned by ethics, safety and communication
* The learners are competent to** SOP - Standard Operating Procedures
1.5 * Analyze specimens and document results.(C) (20 Credits) (NQF 5)
1.6 * Demonstrate the ability to apply computer skills appropriate to the workplace.(C) (2,5 Credits) (NQF 5)

2.1 * Evaluate test results through the application of the knowledge of principles and techniques of the analytical procedures used.(C) (30 Credits) (NQF 5)

2.2 * Evaluate test results through the application of the knowledge of the principles by which different instruments function.(C) (20 Credits) (NQF 5)

Footnote: Underpinned by ethics, safety and communication
* The learners are competent to

2.3 * Correlate and interpret test results through application of a knowledge of physiological and pathophysiological conditions affecting test results.(C) (30 Credits) (NQF 5)

3.1 * Apply principles and concepts of Quality Control to evaluate media, stains, reagents and standards according to established criteria.(F) (8 Credits) (NQF 5)

3.2 * Maintain established quality control procedures in the laboratory.(F) (12 Credits) (NQF 5)

Footnote: Underpinned by ethics, safety and communication
* The learners are competent to

4.1 * Maintain laboratory stock control.(C) (4 Credits) (NQF 5)
4.2 * Apply principles of time management in planning workload.(C) (6 Credits) (NQF 5)
4.3 * Maintain a database of epidemiological records.(C) (10 Credits) (NQF 5)

5.1 * Apply ethical principles.(F) (5 Credits) (NQF 5)
5.2 * Demonstrate professional communication skills.(F) (5 Credits) (NQF 5)
5.3 * Describe the roles of appropriate professional bodies.(F) (5 Credits) (NQF 5)

Footnote: Underpinned by ethics, safety and communication
* The learners are competent to

6.1 * Apply laboratory safety procedures to the collection, transport, storage, analyses and disposal of biological specimens and other substances.(F) (10 Credits) (NQF 5)

6.2 * Describe and demonstrate first-aid procedures (Range : chemical, electrical, fire, gases, radiation, infectious material).(F) (10 Credits) (NQF 5)

6.3 * Describe and apply emergency procedures to be followed in the event of a laboratory accident(s).(F) (5 Credits) (NQF 5)

6.4 * Explain and apply relevant legislation pertaining to safety.(F) (5 Credits) (NQF 5)

Footnote: Underpinned by ethics, safety and communication
* The learners are competent to** OHS Act - Occupational Health and Safety Act

7.1 * Demonstrate effective communication skills in oral, written and electronic format.(F) (7 Credits) (NQF 5)
7.2 * Use medical and technical terminology appropriately.(F) (3 Credits) (NQF 5)
7.3 * Demonstrate the ability to use different computer software programmes.(F) (10 Credits) (NQF 5)
7.4 * Demonstrate the ability to access information electronically or by other means and use information.(F) (5 Credits) (NQF 5)

ASSOCIATED ASSESSMENT CRITERIA

1 Perform the various clinical nuclear medicine investigations using optimal techniques in order to benefit the diagnosis or management of the patient (36)

1.1 Performs both routine and non-routine Nuclear Medicine
? (8 credits) (NQF 6)
1.2 Apply knowledge and understanding of anatomy, physiology and pathology states in the imaging context
? (4 credits) (NQF 6)
1.3 Utilise the correct instrumentation and accessories in a range of routine and non-routine investigations
? (6 credits) (NQF 6)
1.4 Produce routine and non-routine images of optimum quality
? (6 credits) (NQF 6)
1.5 Evaluate the technical quality of the routine and non-routine image
? (5 credits) (NQF 6)
1.6 Evaluate results of routine and non-routine images accurately
? (5 credits) (NQF 6)

2 Administer and manage the nuclear medicine environment in terms of Quality Assurance, Radiation Protection and management to provide a safe environment for the patient and an optimal diagnostic and therapeutic nuclear medicine procedure (18)
2.1 Develop and implement quality assurance programmes.
? (5 credits) (NQF 6)
2.2 Manage all procedures, techniques and patient care (total service)
? (3 credits) (NQF 6)
2.3 Develop self and others within the medical team
? (1 credit) (NQF 6)
2.4 Management skills applied in organisation and administration
? (1 credit) (NQF 5)
2.5 Implement and maintain existing radiation protection laws to ensure the patients, personnel, public and self are protected from unnecessary radiation before, during and after examinations
? (2 credits) CNQF 5)
2.6 Follows appropriate radiation protection procedures
? (1 credit) (NQF 6)
2.7 Performs surveys to monitor equipment and areas
? (2credits) (NQF 6)
2.8 Perform decontamination procedures
? (1 credit) (NQF 5)
2.9 Disposes of radioactive waste
? (1 credit) (NQF 5)
2.10 Participates in teaching programmes to instruct others of radiation hazards
? (1 credit) (NQF 6)

3 Operate and assure quality function of all nuclear medicine instrumentation in order to provide the best diagnostic capability of the instruments (24)
3.1 Evaluates performance of gamma cameras
? (8 credits) (NQF 6)
3.2 Evaluate performance of SPECT cameras
? (8 credits) (NQF 6)
3.3 Evaluates the performance of Nal (T1) scintillation probes and well counters
? (2credits) (NQF 6)
3.4 Operates survey meters
? (2credits) (NQF 6)
3.5 Evaluates the operation of a Dose Calibrator
? (2credits) (NQF 6)
3.6 Operates and maintains film processor
? (2 credits) (NQF 5)

4 Function fully in a radio pharmacy laboratory (type "B" laboratory) (24)
4.1 Assembles, operates and maintains radio-nuclide generators
? (4credits) (NQF 5)
4.2 Applies knowledge of radio pharmaceuticals and their properties to enable accurate preparation of various radio pharmaceuticals
? (10 credits) (NQF 6)
4.3 Administer the laboratory correctly
? (5 credits) (NQF 6)
4.4 Design or organise laboratory layout to ensure function
? (6 credits) (NQF 6)

5 Function effectively in a type "C" laboratory to perform various in vitro nuclear medicine examinations (12)
5.1 Effective management and administration of laboratory
? (2 credits) (NQF 6)
5.2 Prepares patient correctly
? (2 credits) (NQF 6)
5.3 Laboratory equipment is used accurately
? (4 credits) (NQF 6)
5.4 Correct specimen collection and handling
? (4 credits) (NQF 6)

6 Function effectively in the Nuclear Medicine team in performing therapeutic procedures with administered doses of up to 400MBq (6)
6.1 Manages and administers therapeutic procedures
? (3 credits) (NQF 6)
6.2 Prepares therapeutic doses
? (2 credits) (NQF 6)
6.3 Administers therapeutic doses
? (1 credit) (NQF 6)

Critical Outcomes
Identifying and solving problems which display that there was creative and critical thinking in nuclear medicine

Working effectively with others in the health care team and education environment

Ability to manage self with respect to learning, nuclear medicine work and personal contexts

Communicating effectively in the learning and health care environment

Use of science and technology in nuclear medicine

High level of information literacy

Understanding of the place of nuclear medicine within the national health and social system

1.1.1 Routine and non-routine nuclear medicine imaging are performed
1.1.2 Radio pharmaceuticals are administered correctly
1.1.3 Principles of advanced Nuclear Medicine techniques are understood
1.1.4 Safety measures are applied appropriately

1.2.1 Knowledge and understanding of relevant anatomy, anatomical relationships and cross sectional anatomy is shown
1.2.2 Nuclear Medicine techniques are demonstrated
1.2.3 Sound knowledge and understanding of physiology to accurately perform Nuclear Medicine techniques is demonstrated
1.2.4 Knowledge and understanding of disease states, indications and abnormalities that influence the choice of Nuclear Medicine procedures demonstrated
1.2.5 Physiologic alterations that might interfere with Nuclear Medicine investigations are known and understood

1.3.1 Imaging systems are selected and appropriately utilised
1.3.2 Knowledge of imaging systems used are demonstrated
1.3.3 Imaging systems are appropriate to the selected techniques
1.3.4 The principles of nuclear medicine instrumentation are applied
1.3.5 Appropriate operational safety measures are effectively applied

1.4.1 Imaging protocols are appropriately applied
1.4.2 Acquisition parameters are known and appropriately selected
1.4.3 Correct grey scale is correctly used. Proper format for recording final data is chosen and appropriately used
1.4.4 Related diagnostic data for image interpretation is utilised
1.4.5 Acquisition data is processed to obtain maximum information

1.5.1 The image demonstrates the required patient information and medico-legal requirements
1.5.2 All data is labelled correctly and appropriately
1.5.3 Any pitfalls appearing on images are identified and noted appropriately
1.5.4 Relevant corrective measures are known and noted appropriately

1.6.1 Normal and abnormal appearance have been recognised
1.6.2 Information relative to diagnosis or patient management is provided
1.6.3 Normal variants are recognised and noted

1.7.1 The patient's rights to quality care are protected
1.7.2 Situations are assessed, discretion and judgements are exercised
1.7.3 Responsibility is assumed for professional decisions
1.7.4 The patient's bill of rights is observed
1.7.5 Unethical and illegal professional activities are reported to the appropriate authorities
1.7.6 Knowledge and understanding of management of misadministration of radio pharmaceuticals is applied

2.1.1 Quality assurance programmes designed and implemented
2.1.2 Quality control tests completed according to procedure manual, legislation and regulations
2.2.1 Patient studies are optimally scheduled, ensuring appropriateness of study
2.2.2 Effective short and long term decisions regarding the patients are made when the need arises
2.2.3 Communication and co-operation between patients and stakeholders are effectively maintained

2.3.1 Time management is optimally implemented
2.3.2 Conflict resolved
2.3.3 Good liaison and communication within the nuclear medicine team is maintained
2.3.4 Supervision and instruction of student, where applicable, is managed
2.3.5 Verbal and non-verbal skills are demonstrated, appropriate to the situation

2.4.1 Stock control is maintained according to departmental protocol. (Adequate supplies are maintained)
2.4.2 Working environment is kept neat and clean at all times
2.4.3 Imaging, processing, photographic, radiation detection and nursing equipment is responsibly cared for
2.4.4 Required appropriate records are kept

2.5.1 All equipment pertaining to radiation safety and radioactive substances are correctly handled in accordance with legislation
2.5.2 Radiation protection protocols and methods are correctly implemented
2.5.3 Knowledge and understanding of radiation physics and radiobiology is applied to the work environment
2.5.4 Appropriate records are kept
2.5.5 A designated protocol governing receipt, storage and disposal of radio nuclides is adhered to
2.5.6 Protection equipment meets requirements and is correctly utilised

2.6.1 Examinations are performed in the proper sequence
2.6.2 Knowledge and understanding of contraindications for examinations are demonstrated
2.6.3 Proper completion of patient informed consent forms is demonstrated if applicable
2.6.4 A proper review of the patient's history is evaluated to ensure proper indication for examinations
2.6.5 Personnel monitoring devices are used at all times
2.6.6 Appropriate protection methods are used to keep exposure as low as reasonably achievable
2.6.7 Radiation substances are stored using proper methods
2.6.8 Radio nuclides that pose special hazards are identified and handled appropriately

2.7.1 Instruments are calibrated at regular intervals
2.7.2 Surveys of designated locations are conducted periodically
2.7.3 Performs wipe tests where designated
2.7.4 Records all data in standard format

2.8.1 Appropriate methods are used to remove contamination or reduce it to acceptable levels
2.8.2 Area and personnel are monitored
2.8.3 Contaminated material is identified, stored or disposed of according to regulations
2.8.4 Records concerning clean up are maintained

2.9.1 Waste is properly disposed of according to regulations
2.9.2 Appropriate records are maintained

2.10.1 Instruction on appropriate radiation safety measures is provided
2.10.2 Instruction on proper emergency procedures is provided

3.1.1 Required quality control tests are regularly performed
3.1.2 Photographic recording devices are checked
3.1.3 Corrective action initiated where necessary
3.1.4 Required records for quality assurance programme are kept

3.2.1 Required quality control tests are regularly performed
3.2.2 Corrective action initiated where necessary
3.2.3 Required records for Q>A> programme are kept

3.3.1 Required calibration and quality control tests are regularly performed
3.3.2 Corrective action initiated where necessary
3.3.3 Required records for Q>A> programme are kept

3.4.1 Required calibration according to regulations is performed
3.4.2 Required records are kept

3.5.1 Required calibration and quality control tests according to specifications are performed
3.5.2 Corrective action initiated where necessary
3.5.3 Required records are kept

3.6.1 Replenishment chemicals are adequately supplied and available
3.6.2 Film density levels, temperature of water and dryer are regularly monitored
3.6.3 Preventative maintenance is regularly provided

4.1.1 Radio nuclide generators are correctly assembled and checked with various quality control tests
4.1.2 Generators are eluted according to directions
4.1.3 Quality control on eluate is performed
4.1.4 Records are kept of utilisation and disposal of all generators

4.2.1 All radio pharmaceutical preparations are identified and labelled
4.2.2 Aseptic techniques correctly applied
4.2.3 Methods to prepare radio pharmaceutical correctly applied
4.2.4 Correct dosages selected and prepared
4.2.5 Standards correctly prepared
4.2.6 Emergency situations are assessed and acted upon

4.3.1 Adequate laboratory supplies are maintained
4.3.2 Required records are kept

4.4.1 Correct utilisation of space and equipment is done
4.4.2 Effective radiation safety procedures used

5.1.1 Adequate supplies are maintained in the laboratory
5.1.2 Patients are correctly scheduled in most appropriate sequence
5.1.3 Appropriate records are maintained

5.2.1 Every step verified and completed correctly
5.2.2 Patient is correctly identified
5.2.3 Correct instructions are given to the patient and nursing staff regarding specimen collection
5.2.4 Patient history is checked for contraindications

5.3.1 Correct calibration of scales, balances, pH meters etc. is performed
5.3.2 Pipetting devices are correctly used
5.3.3 Temperatures of water baths and refrigerators are maintained

5.4.1 Appropriate equipment for specimen collection is used
5.4.2 Venipuncture is correctly performed at appropriate time intervals
5.4.3 Correct anticoagulants or haemolyzers are added where necessary
5.4.4 Specimens are correctly stored
5.4.5 Accurate aliquots of specimens are taken. Correct separation and labelling of cells is performed

6.1.1 Treatment protocol is verified with a Nuclear Medicine physician and or Medical Physicist
6.1.2 Patient is appropriately scheduled
6.1.3 Appropriate records are maintained

6.2.1 Patient dose is verified by medical physician / physicist

6.3.1 Patient's identity is verified
6.3.2 Patient and nursing staff are given instructions re procedure and precautions
6.3.3 Dose is administered in a designated area, observing all safety precautions
6.3.4 Patient is monitored for an appropriate time interval following administration
6.3.5 Patient's understanding of instructions is verified before discharge from department

Integrated assessment:

Continuous evaluation of theoretical, practical and clinical aspects
Written tests / examinations
Assignments (projects / practicals)
Presentations
Case studies
Clinical assessments

ARTICULATION OPTIONS

Vertical articulation to the First degree in Biomedical Technology.

MODERATION OPTIONS

SERTEC (currently).

CRITERIA FOR THE REGISTRATION OF ASSESSORS

SERTEC (currently).

NOTES

While South Africa still had Technikons, all of their qualifications were registered under the Committee of Technikon Principals. After the Technikons became Universities of Technology or merged with Universities, the qualifications were registered under each of these institutions, and the CTP qualifications fell away (hence the end date of 2006, above). Where relevant, replacement information is s
hown in the table above.

LEARNING PROGRAMMES RECORDED AGAINST THIS QUALIFICATION:

NONE

PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS QUALIFICATION:

This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.

NONE