Proficiency Testing


INTRODUCTION

 
The National Health Laboratory Service (NHLS) was formed in 2001. The NHLS comprises of former South African Institute for Medical Research (SAIMR), the National Institute for Communicable Diseases (NICD), the National Institute for Occupational Health (NIOH) and the former state laboratory services, which between them have provided both a research and diagnostic laboratory service for the public sector in South Africa since 1912. The Kwazulu-Natal (KZN) provincial laboratories were incorporated into the NHLS on 01 October 2006.
 
Part of the function of the NHLS Quality Assurance Division is to provide Proficiency Testing  schemes (PTS) for all laboratory specialties. These schemes, which are under continuous review and are designed to be technically relevant, currently covers Biochemistry, Haematology, Mycobacteriology, Serology (Syphilis and HIV), Flow Cytometry, Bacteriology, Parasitology and Mycology.
 
NHLS QAD provides these PT schemes to all NHLS laboratories in South Africa and laboratories in over 20 countries throughout Africa. The QA Division also co-ordinates and advises on the use of international Quality Assessment Programmes for specialist assays, and has the responsibility for monitoring the quality of service provided by the NHLS laboratories.
 
  1. The following PT Schemes are accredited to ISO/IEC 17043:2010 requirements:-

Chemical Pathology
Therapeutic Drugs
Blood Gases
Endocrinology
General Bacteriology
Flow Cytometry
Full Blood Count and Platelets
Blood Morphology
Manual Reticulocyte Count
Erythrocyte Sedimentation Rate
Parasitology (blood and stool)
RPR and TPHA serology
TB Microscopy
 
Some of the PT Schemes are Continual Professional Development (CPD) accredited by the Society of Medical Laboratory Technologists of South Africa (SMLTSA), and participants are awarded CPD points on successful completion of PT Rounds.
 
The PT Schemes run by the NHLS have been designed with a specific purpose in mind, namely, to measure laboratory performance against established (and best practice) criteria. In order to achieve the highest levels of objectivity, the management of these PT Schemes is carried out by the Quality Assurance Division, Sandringham, Johannesburg which is entirely independent of the core service functions of the NHLS with a line function that reports directly from the NHLS QA Executive Manager to the NHLS Chief Executive Officer (CEO). As a consequence of this structure, the risk of collusion between participants is mitigated, and a level of objectivity is maintained.
 
Accreditation of the PT Schemes infers parity with similar international PT Schemes. In order to achieve this accreditation, many stringent technical requirements must be satisfied, which includes integrity of data, accuracy of results, and preservation of the confidential nature of participant results.

RESULTS (All Schemes)

 
Participants may send results by either facsimile or email, on the forms provided, to the relevant Scheme Manager on or before the nominated closing date. Some PT Scheme Managers may (by arrangement) allow participants to post/mail results, but this is not the preferred method.
 
Because most of the PT Schemes statistically analyse participant performance by comparing individual results to a consensus of the mean, results received after the closing date (and thus after the calculation of the statistical mean) cannot be processed.
 
Results submitted to an incorrect fax number or email address will also not be accepted.
 

REPORTS (All Schemes)

 
Participant results are analysed and distributed before the next survey. Reports are printed and posted to participants. The delivery of these reports is subcontracted to a courier company.
 

NEW APPLICATIONS (All Schemes)

 
All new NHLS laboratories are automatically enrolled by the Business Manager. Participation fees are levied for applicants external to NHLS. Please direct requests for quotations and/or applications to:-
 
Lauren Buckton
e-mail     lauren.buckton@nhls.ac.za
Tel:        0027 (0)11 386-6149
Fax:        0027 (0)11 386-6296
Material for the Schemes is purchased in advance; therefore new applications must be received by the closing date stipulated on the application form in order to be included in the following year’s schemes.
 
Details of schemes offered
 
CHEMICAL  PATHOLOGY
Scheme Manager:  Celeste Mc Pherson                                                   
e-mail: celeste.mcpherson@nhls.ac.za
Tel:     0027 (0)11 386-6143
Fax:     0027 (0)11 386-6296
Twenty-seven parameters are analysed in twelve monthly samples.  Analytes covered are sodium, potassium, carbon dioxide, chloride, magnesium, urea, creatinine, total protein, albumin, calcium, phosphate, cholesterol, glucose, uric acid, total bilirubin, direct bilirubin, triglycerides, alkaline phosphatase, aspartate transaminase, alanine transaminase, lactate dehydrogenase, gamma glutamyl transferase, amylase, creatine kinase, lipase, iron and lactate. The complete set of material is mailed at the beginning of the year together with instructions and result forms.
 
A confidential performance report is issued on a monthly basis to participating laboratories. The information is provided:
1.  The overall mean and standard deviation (SD) and CV for each analyte for all methods. Results outside 2SD are starred and those in excess of 3SD are flagged as wild.
2.  The method mean, SD and CV for specific methodologies.
3.  The z-score, a measurement of bias relative to the overall mean.
 
 
THERAPEUTIC DRUGS (NHLS laboratories only)

Scheme Manager: Celeste Mc Pherson

e-mail: celeste.mcpherson@nhls.ac.za 
Tel:     0027 (0)11 386-6143
Fax:     0027 (0)11 386-6296
 
Six rounds per year are conducted bimonthly. Analytes covered include: acetaminophen, carbamezepine, digoxin, lithium, phenobarbitone, phenytoin, salicylate, theophylline, valproic acid and the antibiotics: amikacin, gentamycin and vancomycin. Results are compared against target values for specific systems with acceptable limits derived from the US CLIA requirements.
 
BLOOD GASES (NHLS laboratories only)

Scheme Manager: Celeste Mc Pherson

 e-mail: celeste.mcpherson@nhls.ac.za
Tel:     0027 (0)11 386-6143
Fax:     0027 (0)11 386-6296
 
Six rounds per year are conducted bimonthly. The assays assessed are pH, pCO2 and  pO2 at two levels per survey. Results are compared against target values for specific systems with acceptable limits derived from the US CLIA requirements.
 
ENDOCRINOLOGY (NHLS laboratories only)

Scheme Manager: Celeste Mc Pherson

e-mail: celeste.mcpherson@nhls.ac.za
Tel:     0027 (0)11 386-6143
Fax:     0027 (0)11 386-6296
 
Six rounds per year are conducted bimonthly.  Analytes covered are α-foetoprotein, CEA, cortisol, βHCG, free T3, free T4, FSH, LH, oestradiol, progesterone, prolactin, PSA, testosterone, and TSH. Results are compared against target values for specific systems with acceptable limits derived from the US CLIA requirements.
 
HAEMATOLOGY
FULL BLOOD COUNT AND PLATELETS

Scheme Manager: Lauren Buckton                                               

e-mail: lauren.buckton@nhls.ac.za                       

Tel:     0027 (0)11 386-6149                         
Fax:     0027 (0)11 386-6296                         
 
Twelve rounds a year (one per month) are sent out. Two stabilized human whole blood samples are provided for the determination of white and red cell counts, haemoglobin, haematocrit, mean cell volume and platelets.
 
A confidential performance report is issued on a monthly basis to participating laboratories. The following information is provided:
 

  1. The overall mean and standard deviation (SD) and CV for each test parameter for all methods. Results outside 2SD are flagged.
  2. The method mean, SD and CV for specific methodologies.
  3. The z-score, a measurement of bias relative to the overall mean.
 
 COAGULATION

Scheme Manager: Lauren Buckton                                               

e-mail: lauren.buckton@nhls.ac.za                       

Tel:     0027 (0)11 386-6149                         
Fax:     0027 (0)11 386-6296
 
Twelve rounds a year (one per month) are sent out. Two lyophilised plasma samples for the determination of International Normalised Ratio (INR) and Activated Partial Thromboplastin Time (APTT). Participant performance is compared to the Consensus of the Mean in the INR PTS; and participant results are compared against target values derived from referee laboratories in the APTT PTS.
 
BLOOD MORPHOLOGY
Scheme Manager: Hazel Aggett    


hazel.aggett@nhls.ac.za     

Tel:     0027 (0)11 555-0413
Fax:  0027 (0)11 386-6296
 
Twelve rounds a year (one per month) are sent out. Two stained blood films for differential cell counts, morphology and interpretative comments. Feedback is given on the laboratory performance as well as all laboratory results relevant to the work-up of each slide presentation. These are used by the participants for reference purposes.
 
MANUAL RETICULOCYTE COUNTS

Scheme Manager: Hazel Aggett    

e-mail: hazel.aggett@nhls.ac.za     

Tel:     0027 (0)11 555-0413
Fax:  0027 (0)11 386-6296
 
Three rounds (minimum) a year are sent to participants. One stained blood film is provided for the manual determination of reticulocyte counts. Feedback is given on the laboratory performance as well as all laboratory results relevant to the work-up of each slide presentation. These are used by the participants for reference purposes.

ERYTHROCYTE SEDIMENTATION RATE (ESR)

Scheme Manager: Lauren Buckton                                               

e-mail: lauren.buckton@nhls.ac.za                       

Tel:     0027 (0)11 386-6149                         
Fax:     0027 (0)11 386-6296
 
Two rounds per annum are sent to participants. One stabilised human whole blood sample is provided for the determination of ESR. Participant performance is measured against the Consensus of the Mean.
 
BACTERIOLOGY (GENERAL)     
                                                             

Scheme Manager: Zazi Molebatsi

e-mail:  bactpts@nhls.ac.za  /  zazi.molebatsi@nhls.ac.za
Tel:     0027 (0)11 885-5353
Fax:     0027 (0)11 386-6296
 
Rounds are issued three times per year. Each round consists of 4 challenges: specimens A-D. Isolates are selected to cover one or more of the following challenges: bacteriological identification, antimicrobial susceptibility testing and clinical relevancy. The paper challenge tests the laboratory’s response to pre-and post-analytical situations.
 
The material supplied consists of lyophilised cultures, simulated specimens, microscopic preparations, general instructions and laboratory response forms. 10-20% of the prepared samples are retained for weekly quality control. This is to check for organism viability until the closure of the round.
 
Participants are evaluated on relevant aspects of laboratory processing, including microscopy, culture and identification, antimicrobial susceptibility testing and reporting. The capabilities of laboratories are taken into account in evaluation of responses (academic, regional or peripheral).
 
Each laboratory receives an individual report and analysis of their performance; a commentary with a review of overall laboratory performance, a teaching exercise on a relevant aspect of laboratory performance and if necessary a corrective action form.
 
MYCOBACTERIOLOGY

  1. TB Microscopy
Scheme Manager: Esther Tsheola                      
e-mail: tbpts@nhls.ac.za / esther.tsheola@nhls.ac.za                 
Tel : 0027 (0)11 555-0344                           
Fax: 0027 (0)11 555-0430                       
 
Rounds are issued three times per year and consist of a panel of ten slides. Five of which are stained by the Ziehl-Nielsen method prior to sending and the other five are to be stained by the participant with a method of their choice. Laboratories are requested to scan the slides and grade the results according to the IUALTD.
 

  1. TB Culture
Scheme Manager: Esther Tsheola                      
e-mail: tbpts@nhls.ac.za / esther.tsheola@nhls.ac.za                 
Tel : 0027 (0)11 555-0344                           
Fax: 0027 (0)11 555-0430
TB Culture rounds are issued twice a year (1st and 2nd surveys). Each round consists of 2 specimens for culture, and identification only and two specimens for culture, identification and susceptibility testing. Laboratories are graded on the accuracy of their identification and susceptibility result.  Each laboratory receives an individual report with their results and score.
 
MYCOLOGY

  1. Yeasts/ Basic Mycology
  2.  

Scheme Manager: Benjamin Mogoye

e-mail: mycopts@nhls.ac.za / benjamin.mogoye@nhls.ac.za

Tel:     0027 (0)11 555-0563
Fax:     0027 (0)11 386-6296
Three rounds per year are conducted. The Basic Mycology PT Scheme tests the laboratory’s proficiency at detecting the presence or absence of fungal elements on microscopy and basic identification of yeast isolates. All laboratories that perform bacteriology should have proficiency in these aspects of mycology.
 
The Basic Mycology PT Scheme consists of two specimens.     

  • One is a slide for staining and microscopy.
  • The other is either lyophilized cultures or cultures suspended in distilled water, for culture and identification.
 
Participants are required to identify the organisms up to the level that they would normally go with clinical specimens and comment on the pathogenicity and significance of the organisms isolated. A confidential performance report containing the correct identification, the optimized procedure and comments on significance is issued to participants.
 
MYCOLOGY

  1. Moulds/ Advanced Mycology
  2.  

Scheme Manager: Benjamin Mogoye

e-mail: mycopts@nhls.ac.za / benjamin.mogoye@nhls.ac.za

   Tel:     0027 (0)11 555-0563
   Fax:     0027 (0)11 386-6296
Three rounds per year are conducted, consisting of either lyophilised cultures or cultures suspended in distilled water. The Advanced Mycology PT Scheme is intended for those laboratories that routinely process specimens for mycology culture and identification.
Four specimens are sent in each round.

  • Three of the four specimens are marked.
  • The fourth specimen is a bonus isolate. This allows for the less common organisms to be included in the PT Scheme. It serves as a teaching exercise and as a challenge for those laboratories that are proficient in mycology.
 
Participants are required to identify the organisms up to the level that they would normally go with clinical specimens and comment on the pathogenicity and significance of the organisms isolated. A confidential performance report containing the correct identification, the optimised procedure and comments on significance are issued to participants.
 
PARASITOLOGY

  1. Stool Parasites 

Scheme Manager: Benjamin Mogoye                                                                    

e-mail: parapts@nhls.ac.za / benjamin.mogoye@nhls.ac.za

Tel:     0027 (0)11 555-0563
Fax:     0027 (0)11 386-6296
 
Three rounds are sent out a year, each comprising ±5 challenges. Round challenges encompass parasite identification and laboratory techniques (such as staining). A teaching series is included in every round to encourage participants to learn more about medically important parasites.
 
PARASITOLOGY

  1. Blood Parasites 

Scheme Manager: Benjamin Mogoye

e-mail: parapts@nhls.ac.za / benjamin.mogoye@nhls.ac.za

Tel:  0027 (0)11 555-0563
Fax:  0027 (0)11 386-6296

                                                                 

Three rounds are sent out a year, each comprising ±5 challenges. Round challenges encompass parasite identification and laboratory techniques (such as staining). A teaching series is included in every round to encourage participants to learn more about medically important parasites.  
 
 
PARASITOLOGY

  1. Pneumocystis jirovecii IFA

Scheme Manager: Benjamin Mogoye

e-mail: parapts@nhls.ac.za / benjamin.mogoye@nhls.ac.za

Tel: 0027 (0)11 555-0563
Fax: 0027 (0)11 386-6296
 
One round is sent out a year, comprising ±5 challenges. Each challenge is a smear which must be stained and examined by participants as per their routine method. Positive controls may be included to assist participants.
Individual reports are issued to each participant detailing their performance, and summarizing the Round’s results. Results are accompanied by a detailed commentary.
 
SEROLOGY
RPR Serology

Scheme Manager: Zazi Molebatsi               

e-mail: seropts@nhls.ac.za / zazi.molebatsi@nhls.ac.za               
Tel :    0027 (0)11 885-5353
Fax:     0027 (0)11 386-6296
                  
This PT Scheme is issued three times per year. Rounds consist of 3 serum specimens. Laboratories are requested to perform non-treponemal syphilis testing on these specimens and to record the titre if specimens are positive. Grading of the laboratories is two-fold being both qualitative and quantitative. Laboratories are issued with reports detailing their performance compared with other laboratories using the same test kit.
 
TPHA Serology

Scheme Manager: Zazi Molebatsi               

e-mail: seropts@nhls.ac.za / zazi.molebatsi@nhls.ac.za               
Tel : 0027 (0)11 885-5353
Fax: 0027 (0)11 386-6296

TPHA serology
This PT Scheme is also issued three times per year. Rounds consist of 3 serum specimens. Laboratories are requested to perform treponemal syphilis testing on these specimens. Laboratories are graded qualitatively for this programme only. Laboratories are issued with reports detailing their performance compared with that of all the laboratories as a whole.
 
HIV Serology

Scheme Manager: Mahlatse Maleka
email: seropts@nhls.ac.za / mahlatse.maleka@nhls.ac.za
Tel: 0027 (0)11 386-6159
Fax: 0027 (0)11 386-6296
 
Three rounds are conducted per year using stabilized human serum with six samples per round. Sample pools are evaluated against a selection of routinely used HIV test kits before distribution to participants. Participant results must be returned to the HIV Serology Scheme Manager.
 
  
FLOW CYTOMETRY (CD4 / T-Cell monitoring)

Scheme Manager: Hazel Aggett

email: hazel.aggett@nhls.ac.za
Tel:     0027 (0)11 555-0413
Fax:     0027 (0)11 386-6296
 
The Immune Monitoring scheme issues stabilised whole blood which participants are required to determine the lymphocyte subsets within the preparation. The following markers are offered:

  • CD4+ Absolute count
  • CD4+ (CD3+CD4+) Absolute count
  • CD3+CD8+Absolute count
  • CD3+Absolute count
  • CD4+ Lymphocyte percentage
  • CD4+ (CD3+CD4+) Lymphocyte percentage
  • CD3+CD8+ Lymphocyte percentage
  • CD3+ Lymphocyte percentage
  • CD19+ B cells Absolute count
  • CD3-/CD16+/CD56+ Natural killer cells Absolute count
  • CD19+ B cells Lymphocyte percentage
  • CD3-/CD16+/CD56+ Natural killer cells Lymphocyte percentage
 
Each laboratory performance report includes the performance of all laboratories (all technologies). The report includes the following:

  • Results of survey number, trial number and sample A and sample B
  • An immunophenotyping results verification sheet that summarises the information submitted by the participant and identifies the institution, laboratory participant number, the lysing protocol, flow cytometer, serial number, monoclonal antibody panel, and phenotyping results.
  • A summary table of statistics that includes: reported value (laboratory submitted result), aggregate group mean value (method mean), residual, SD, %CV and SDI (z-score).
  • A cumulative SDI (z-score) graphical representation of performance, which illustrates the laboratory’s SDI (z-score) value, within the group distribution.
Specimens are distributed to participating laboratories six times per cycle.
__________________________________________________________________________
 
APPEALS
 
Please direct all appeals regarding scoring/ evaluation of your performance to the relevant Proficiency Scheme Manager using the contact details published in this booklet.
 
COMPLAINTS/ FEEDBACK
 
We value your feedback. Please direct your comments and suggestions to:


Ms Patience Dabula

National Quality Assurance Manager
NHLS
Private Bag X8
Sandringham
2131   
South Africa
Phone: 0027 (0)11 386-6151/6147
e-mail: patience.dabula@nhls.ac.za