Quality Control (QC) & Training Department
National Public Health Laboratory is an ISO 15189: 2012 accredited laboratory. Many quality related activities and training are conducted under this sections. Various National External Quality Assurance Programs (NEQAS) are being operated throughout the country through this department.
ISO 15189:2012 accreditation continuation
National public health laboratory has been assessed and accredited in accordance with ISO 15189:2012 in the discipline of clinical chemistry, immunology, serology, hematology and molecular testing since 2020. Initially a total of 66 test were within the scope of ISO accreditation, last fiscal year 72 new test are added to the list.
NEQAS Programs in NPHL
Table 1: List of NEQAS programs offered by NPHL
|
SN |
NAME OF PROGRAM |
TARGETED LAB |
FREQUENCY OF CYCLE |
STARTED |
|
1 |
General/Basic NEQAS program
|
All lab /hospital/ clinic/polyclinic/ of government, semi-government & private sectors |
3 times of years (Shrawan- Bhadra, Mangsir- Poush & Chaitra- Baishak)
|
1987 AD |
|
2 |
Dried tube specimen (DTS) EQA program - HIV 1 & 2 rapid test & ELISA |
HIV testing sites only |
Twice a year (Ashwin & Chaitra) |
2021 AD |
|
3 |
EQA program for bacteriology - Bacteria Identification - Antimicrobial Susceptibility Testing (AST) |
AMR SITES |
4 times a year (March, June, Sep & Dec) |
2005 AD |
|
4 |
CD 4 EQA program (distribution only) - CD 4 count |
CD 4 testing sites (28) |
Bimonthly |
|
|
5 |
Transfusion Transmitted Infections (TTIs)serology for blood transfusion service centre (NEQAS –TTIs) a. HIV 1 & 2 b. Hepatitis B Virus Surface Antigen (HBsAg) c. Anti HCV antibody d. Syphilis Antibody |
For all Blood Transfusion service center of Nepal. |
2 times of Year (Shrawan- Bhadra & Chaitra- Baishak.) |
2012 AD |
|
6 |
COVID-19 PCR EQAS proficiency test |
For all COVID-19 PCR Sites |
4 times of year Shrawan, Magsir, Falgun, Baishak |
2020 AD |
|
7 |
COVID-19 PCR EQAS Retesting |
For all COVID-19 PCR Sites |
Monthly |
2020 AD |
General/Basic NEQAS program
NEQAS program was started in NPHL in 1987 AD with the support of the International Nepal Fellowship (INF). In earlier phase government laboratories were enrolled in NEQAS programs, which now have been extended to the private sector too. NEQAS program is schedule for three times a year. Proficiency panel are prepared and sent to participating laboratories. After analysis of report from laboratories, feedback is sent to them along with next lot panel.
There are total 26 proficiency panels prepared for general NEQAS program, they are:
- Hematology panel: HB, Total WBC count, Total RBC count, DC, Platelets, PCV, PBS.
- Clinical biochemistry panel: Lyophilized serum for glucose, urea, creatinine, uric acid, total protein, albumin, potassium, total cholesterol, HDL Cholesterol, SGPT, SGOT, Sodium, Potassium, LDH, Gamma GT, Total Bilirubin, Direct Bilirubin, CK Total,
- Microbiology panel: Gram stain slide.
The activities and their progress in the fiscal year 2078-2079 have been listed below:
|
Lot no. |
Total no of participating labs. |
Government Lab |
Private Lab |
No of responding lab. |
Private lab responders |
Government lab responders |
Number of labs with Score based on SDI range (%) |
|||
|
+/- 0-1 |
+/-1-2 |
+/- 2-3 |
+/- 3 |
|||||||
|
48 (78-shrawan) |
654 |
201 |
453 |
288 (44%) |
224 (77.7%) |
64 (22%) |
10-25% |
40-60% |
10-15% |
|
|
49 (78-Poush) |
603 |
211 |
392 |
344 (57%) |
271 (78.5%) |
73 (21%) |
30-35 |
55-65 |
12-18 |
|
|
50 (79-Jaestha) |
610 |
215 |
395 |
373 (61%) |
289 ( 77.2%) |
84 (22%) |
30-33 |
50-60 |
15-20 |
|
Transfusion Transmitted Infections (TTIs) serology for blood transfusion service centre (NEQAS –TTIs)
Under this program, PT Panel for test related to Blood transfusion service (HIV I & 2, HBsAg, HCV and VDRL) is sent to BTS sites twice a year. A total of 60 sites at each lot were enrolled in the last fiscal year
|
Batch Number |
Total Sent |
Responding BTSCs |
Grade |
Unresponsive |
|
NTQ-1 (Bhadra 2078)
|
114 |
60 |
Excellent- 37 Need to improve – 21 Unacceptable -2 |
54 |
|
NTQ-2 (Baisakh 2079)
|
120 |
60 |
Excellent- 50 Need to improve - 10 |
60 |
Performance is evaluated as below:
- BTSC Scoring 100% in NEQAS - Excellent performance
- BTSC Scoring 90-100% Need to improve performance.
- BTSC Scoring below 90% Unacceptable performance (Urgent action needed to review the technical competency of the BTSC)
EQAS for HIV testing:
Various EQA scheme are running for HIV testing laboratories. Some of them are:
- Proficiency panel testing of HIV Serology using Dried Tube Specimen (DTS):
This program is conducted twice a year. Samples are prepared by NPHL and are sent to participating laboratories via respective Provincial Public Health Laboratories. Performance result of one of the batch is as following:
Duration: April 2022-June 2022
|
Performance Evaluation |
||||||
|
SITE |
Batch |
Total participants |
Excellent(100%) |
90-100 |
80-90 |
<80 |
|
PPHL SUDURPASCHIM |
NPHL-HIV-PT3 |
23 |
8 |
0 |
1 |
14 |
|
PPHL LUMBINI PROVINCE |
NPHL-HIV-PT3 |
26 |
21 |
0 |
3 |
2 |
|
PPHL-1(BIRATNAGAR) |
NPHL-HIV-PT3 |
18 |
8 |
0 |
2 |
8 |
|
PPHL (KARNALI PROVINCE) |
NPHL-HIV-PT3 |
8 |
6 |
0 |
1 |
1 |
|
PPHL (BAGMATI PROVINCE) |
NPHL-HIV-PT3 |
22 |
11 |
0 |
3 |
8 |
|
PPHL(GANDAKI PROVINCE) |
NPHL-HIV-PT3 |
18 |
8 |
0 |
1 |
9 |
|
PPHL (MADHESH PRADESH) |
NPHL-HIV-PT3 |
12 |
6 |
0 |
2 |
4 |
|
Total |
127 |
68 |
0 |
13 |
46 |
|
CD4 EQAS:
Under this scheme, EQA samples are distributed by NPHL to CD4 testing labs throughout the country. These samples are obtained from Siriraj Hospital Bangkok, Thailand and evaluation is also done by the same institute. NPHL receives the feedback after submitting the results and the same is forwarded to concerned laboratories. It’s a bimonthly program where samples are sent to participating laboratory once in every 2 months.
EQA program for bacteriology:
NEQAS in Bacteriology is conducted only for AMR surveillance sites since 2000 A.D. NPHL dispatches four batches of EQAs each year to all participating laboratories. Laboratories are required to identify the given organism and perform Antibiotic Susceptibility test and report it in a standard format that is provided. The received results are compiled and scored according to WHO scoring system. Feedback of each batch is sent along with the samples of next EQAs batch.
|
Lot number |
Date |
Number sample dispatched labs |
Results obtained from |
Average score in % |
|
2/2021 |
078- Bhadra |
22 |
13 (59.1%) |
88.5% (IDEN) 83.8% (AST) |
|
3/2021 |
078- Poush |
22 |
17 (77.3%) |
93.1%(IDEN) 88.2% (AST) |
|
1/2022 |
078-Chaitra |
26 |
17 (65.4%) |
85.3%(IDEN) 78.2% (AST) |
|
2/2022 |
079- Jestha |
26 |
19 (73.1%) |
72.8%(IDEN) 80.8% (AST) |
Quality assessment on Covid-19 test (COVID-19 PCR EQAS proficiency test & COVID-19 PCR EQAS Retesting
Various EQA schemes are in function for COVID-19 PCR labs. Like: retesting, Proficiency testing and onsite supervision.
EQA by retesting:
This EQA scheme for COVID-19 PCR labs was initiated in June-July 2020. This is a monthly program in which retesting is performed on a defined number of samples sent from participating labs. 10 positive samples and 10 negative samples are received from each individual CoVID-19 PCR testing sites which are retested at NPHL and the feedback is sent back.
|
YEAR |
Month |
Total Number of Labs |
Number of labs participated |
% of Lab participated |
|
2078 |
Shrawan |
90 |
46 |
51 |
|
Bhadra |
90 |
56 |
62 |
|
|
Asoj |
95 |
47 |
49.4 |
|
|
Kartik |
96 |
42 |
43.7 |
|
|
Mangsir |
96 |
49 |
51 |
|
|
Poush |
99 |
33 |
33 |
|
|
Magh |
99 |
42 |
42 |
|
|
Falgun |
103 |
21 |
20 |
|
|
Chaitra |
103 |
29 |
28 |
|
|
2079 |
Baishak |
94 |
26 |
27 |
|
Jestha |
94 |
17 |
18 |
|
|
Asadh |
94 |
10 |
10 |
PT panel EQA:
This program started from Sept- Oct 2020. This a tri-monthly program in which proficiency panels are prepared at NPHL, coded, and sent to designated COVID-19 laboratories. Samples are tested at sites and results are sent back to NPHL. NPHL then provides the sites with feedback reports.
|
PT Batch |
No. of labs to which PT panel was dispatched |
No. of responding labs (%) |
|
1 (Bhadra/ Asoj 2078) |
88 |
82 (93%) |
|
2 (Mangshir -2078) |
96 |
87(90.65%) |
|
3 (Falgun -2078) |
93 |
87 (93.54%) |
|
4 (Jestha/Shrawan- 2079) |
83 |
79 (95%) |
Validation activities:
Validation activities are being conducted by QC and training department. Validation is mainly focused on COVID-19 PCR labs and related diagnostic items.
List of PCR labs being validated by NPHL in the fiscal year 2078-2079:
|
Province |
Number of labs validated |
|
|
Government |
Private |
|
|
1 |
- |
- |
|
Madhesh |
- |
- |
|
Bagmati |
|
14 |
|
Gandaki |
- |
- |
|
Lumbini |
- |
- |
|
Karnali |
- |
- |
|
Sudurpashchhim |
- |
- |
|
Total |
- |
14 |
List of diagnostic items validated/ evaluated by NPHL in fiscal year 2078-079:
|
Type of kit |
Validation type |
Total number |
|
COVID-19 PCR Kit |
Paper evaluation |
2 |
|
Bench evaluation |
11 |
|
|
COVID- 19 Ag Kit |
Paper evaluation |
4 |
|
Bench evaluation |
|
|
|
VTM |
Paper evaluation |
2 |
|
Bench evaluation |
|
|
|
Extraction kit |
Paper evaluation |
6 |
|
Bench evaluation |
2 |
|
|
Others |
Paper evaluation |
3 |
|
Bench evaluation |
2 |
Trainings:
The training section facilitates the laboratory staff to acquire and update laboratory knowledge and skills for the smooth functioning of clinical laboratory. Many in house and inter laboratory trainings are conducted in NPHL. Below is the list of the training conducted in last fiscal year (2078/2079):
In-house Training/Orientation:
|
S.N |
Training Name |
Date |
No of participants |
|
1 |
Training on laboratory Critical Value alert |
2078/04/32 |
20 |
|
2 |
Orientation training on SIEMENS |
2078/05/16 |
25 |
|
3 |
Orientation training for Billing Counter and Report Dispatch |
2078/7/04 |
14 |
|
4 |
Workshop on how to conduct research and publish it. (First phase)
|
2078/07/06 - 07 |
20 |
|
2078/11/23 |
20 |
||
|
6 |
Orientation training on IPC & waste management to supporting staff of NPHL |
2078/07/14 |
7 |
|
7 |
Training on Gene sequencing |
2078/07/20 and 2078/09/06 |
18, 24 respectively |
|
9 |
Demonstration of Fire drill |
2078/09/18 |
30 |
|
10 |
Application training on EQA by UK Randox |
2078/09/27 |
20 |
|
11 |
Training on interpretation of results of automated cells counter |
2078/09/28 |
15 |
|
12 |
Orientation training on CLINOX operating system |
2078/09/29 |
20 |
|
14 |
Training on Quality Indicator |
2078/11/23 |
23 |
|
15 |
Training on autoclave operating system |
2078/03/15 |
8 |
Inter laboratory Training/Orientation:
|
S.N |
Training Name |
Date |
No of participants |
|
1 |
Orientation on Bio safety / Biosecurity and Health care waste management and Isolate shipping and Transportation. |
2078/04/13 |
16 |
|
2078/04/18 |
17 |
||
|
2078/04/20 |
16 |
||
|
2078/04/32 |
14 |
||
|
2078/05/10 |
16 |
||
|
2078/05/15 |
16 |
||
|
2078/05/17 |
20 |
||
|
2078/05/24 |
15 |
||
|
2078/05/30 |
14 |
||
|
8 |
Local Level Lab Inspection Category D and E Virtual orientation Training kathmandu, Bhaktapur, Lalitpur district |
2078/05/23 |
40 |
|
9 |
Skilled based “ Hands on microbiology laboratory placement training |
2078/05/24 |
3 |
|
12 |
Local Level Lab Inspection Category D and E Virtual orientation Training Province 1 – Province 7 |
2078/06/05 – 2078/06/15 |
Approximately 50-60 |
|
19 |
EID Training Province no 1, Sudurpaschim, Gandaki, Bagmati. |
2078/06/17 |
20 |
|
2078/07/07 |
23 |
||
|
2078/07/14 |
20 |
||
|
2078/11/11 |
17 |
||
|
20 |
Implementation workshop of ESBL tricycle Project |
2078/06/23 |
40 |
|
22 |
Incitation Meeting of Integrated Influenza SAARS CoV-2 Sentinel Surveillance in Nepal |
2078/07/10 |
60 |
|
24 |
Consultative meeting Experts integrated Influenza SAARS CoV-2 Sentinel Surveillance in Nepal |
2078/07/16 |
16 |
|
25 |
Polio Transport Meeting |
2078/08/02 |
30 |
|
26 |
National Training on Integrated Influenza SAARS CoV-2 Sentinel Surveillance in Nepal |
2078/08/12 |
40 |
|
27 |
ART Councillor HIV Viral Load sample Collection Transport And data Management |
2078/08/15 to 2078/08/17 |
26, 17,15 respc. |
|
30 |
Training of trainers on Biosafety/Biosecurity |
2078/08/19 |
10 |
|
31 |
Data Analytics introductory training |
2078/08/20 |
10 |
|
32 |
Component preparation Training |
2078/08/22 |
21 |
|
33 |
Hands on microbiology placement training |
2078/08/26 |
5 |
|
34 |
Quality assurance and quality control in bacteriology laboratory |
2078/09/27 |
10 |
|
35 |
Implementation meeting of integrated influenza SARS cov 2 in Pokhara, Biratnagar, surkhet, Janakpur, Lumbini |
2078/11/5 |
20 |
|
2079/02/13 |
20 |
||
|
2079/03/3 |
19 |
||
|
2079/03/9 |
20 |
||
|
2079/03/12 |
27 |
||
|
36 |
DHIS2 data analyses training |
2078/11/08 |
20 |
|
38 |
Excel training for AMR surveillance data management |
2078/11/29 |
25 |
|
39 |
Workshop on preparation local antibiogram & antimicrobial guideline |
2078/12/21 |
20 |
|
41 |
Lab Clinic Interface AMR |
2079/02/30 |
30 |
|
2079/03/03 |
20 |
||
|
2079/03/05 |
30 |
||
|
42 |
Laboratory waste management orientation training in Surkhet |
2079/03/09 |
18 |