ABOUT NEQAS OF NPHL National Public health Laboratory (NPHL) is the government national reference laboratory under the Department of health services (DoHS) and Ministry of Health and Population (MoHP). It is directly linked with different levels of government laboratories in the country. It was established in 1968 as Central Health Laboratory. The name was changed to National Public Health Laboratory in 1991 with the mandate for organizational and administration responsibilities for the health laboratory services (public health and clinical diagnostic) in both public and private sectors throughout the country. Networking, Licensing, monitoring, supervision, capacity, strengthening and conducting research activities and NEQAS of the laboratories are the major functions of NPHL.

NEQAS Unit has been established in NPHL in 1997 AD with the collaboration of the International Nepal Fellowship (INF). In earlier phase government laboratories were enrolled in NEQAS programs, which now has been extended to the private sector. Besides improvement in the quality of laboratory result NEQAS program are also is helping in policy making by making suggestion to higher authorities in the preparation of laboratory standards.

Table 1: List of NEQAS programs offered by NPHL

SN NAME OF PROGRAM TARGETED LAB FREQUENCY OF STARTED CYCLE 1 General/Basic NEQAS program All lab /hospital/ 3 times of years 1997 AD a. Basic clinical Biochemistry clinic/polyclinic/ of (Shrawan- , Mangsir- & Chaitra- Baishak) b. Basic Haematology government, semi-

c. Gram’s stain ‘ government & private d. Peripheral blood smear ( PBS morphology) sectors

2 Dried tube specimen (DTS) EQA program HIV testing sites only Twice a year ( 2021 AD - HIV 1 & 2 rapid test & ELISA & Chaitra) 3 EQA program for bacteriology AMR SITES 4 times a year 2005 AD - Bacteria Identification ( March, June, Sep & Dec) - Antimicrobial Susceptibility Testing (AST) 4 CD 4 EQA program ( distribution only) CD 4 testing sites (28) Bimonthly - CD 4 count 5 Transfusion Transmitted Infections (TTIs)serology for blood For all Blood Transfusion 2 times of Year 2012 AD transfusion service centre (NEQAS –TTIs ) service center of Nepal. (Shrawan- Bhadra & Chaitra- Baishak.) a. HIV 1 & 2 b. Hepatitis B Virus Surface Antigen ( HBsAg) c. Anti HCV antibody d. Syphilis Antibody 6 COVID-19 PCR EQAS proficiency test For all COVID-19 PCR 4 times of year 2020 AD Sites Shrawan, Magsir, , Baishak 7 COVID-19 PCR EQAS Retesting For all COVID-19 PCR Monthly 2020 AD Sites

FOR DETAILS CONTACT The participants are requested to contact us for any quarries. Contact us E mail, [email protected], : [email protected] Phone No : +977-1-5352421 ( 9 am -3 pm) or direct contact in NEQAS department of NPHL. Note: All NEQAS programs are raised & upgraded in regular intervals as per demand of time. In the beginning of NEQS data analysis done by manually but now we are trying to extend web-based software

GENERAL/BASIC NEQAS PROGRAM Department of Quality control, NPHL, Teku, Kathmandu, Nepal is conducting National External Quality Assurance (NEQAS) basic/ general scheme. Starting from 1997 AD (Lot No 01), till this 2077 year running 46 lot.

TARGET PARTICIPANTS: The participants include all laboratories in country, both government, semi- government & private & hospital based /polyclinic based & standalone labs.

 Government: Health post Lab, PHC lab, Provincial Hospital Lab, National Hospital lab,  Semi government: Includes Medical colleges, other institution  Privet sectors: incudes D, C, B, A categories lab, Registered hospital labs clinic, polyclinic, diagnostic centers, research centers.

NUMBER OF PARTICIPANTS /CRITERIA FOR PARTICIPANTS FOR NEQAS PROGRAM - Should be registered in Nepal Government (copy of registration related document under the MOHP/ NPHL/ DHS/ DHO/Local government health office) - Latest copy of tax clearance document. - Application letter with detail lab information. OR - Online registration through neqas.nphl.gov.np ( Please visit site for details )

Note: - Conformation from NPHL ADMIN BY CHECKING OF LAB DETAILS AND PARTICIPATION OR RENEWAL FEE OR CHARGE THROUGH BANK VOUCHER OR OTHER ONLINE PROCEDURE DOCUMENT. - Total Participants number are till 46 lot are 700 +, - But active participants are till 46 lots 555 in number including government 175, Private sector 380.

FREQUENCY / TIMES OF YEAR - It is conducted 3 times (3 lots) in a year - Program starting from Shrawan- Bhadra, Mangsir- Poush & Chaitra- Baishak. - Those who wish to enroll their laboratories during the cycle can apply any timeof year via the online registration.

Program scheme & sample are labeled in vial & slide as:  Heamatology sample: as latest lot no . 1 ( eg 46.1) Scheme Parameter: Hb%, WBC, RBC  Peripherial blood smear slide as latest lot no . 2 ( eg 46.2) For peripherial blood smear comments.  Biochemistry: as latest lot no. 1 ( eg 46.3) Parameter of scheme includes: Glucose, Urea, creatinine, T Protein, Albumin, Uric acid, T Cholestrol , HDL cholesterol , Sodium, Potassium, AST/GOT & ALT/GPT.  Gram slide (as latest lot no . 1( 46.4) For Gram’s staining comment. Note: above label format can be conform by final software handling / admin

VISIT : www.nphl.gov.np ------click Quality Assurance ----- click Link to NEQAS software – create your account with detail ------select method------after creating account ----you will received lot and enter your report

visit: http://www.nphl.gov.np/

click : Link to NEQAS (Upper Right Corner of the Website)

click to: Create an Account! & fill up your lab/hospital details

register

o;/L /lh:6«]zg ul/ ;s]kl5 ! b]vL @ lbg leq tkfO{sf] ID e]l/kmfO{ x'G5 .

Verificate email k|fKt eO;s]kl5 cfˆgf] user id/password /flv login ug'{xf];\ .

Choose Method df uO{ cfˆgf] method choose u/L gofF n6sf] result entry u/L submit ug'{xf]nf .

For Details: refer to user MANUAL or NPHL NEQAS section. The participants are requested to contact us for any quarries. Contact us E mail : [email protected], [email protected] Phone No : +977-1-5352421 ( 9 am -3 pm) or direct contact in NEQAS department of NPHL.

STATISTICAL TOOL FOR REPORT ANALYSIS

Evaluation of the report is based on Robust mean for the assigned value & SDI (Z score) for individual parameters of quantitative section ( Haematology & Biochemistry). The qualitative section (Grams stain & PBC comment) are matching to NPHL known result and result are generate by scoring system.

i. Quantitative section : Hematology, Biochemistry ii. Qualitative section: Gram Stain and PBS Morphology

Statistical Tools used are:

 Mean (Designated value DV): the robust mean is ratio of total sum of values to total number of participants as per specific method.

 SDI (Standard Deviation Index): The standard deviation index is measurement of bias (how close your value is to the target value). SDI = your result – Designated value (DV or mean) / SD of Mean of comparison group

 CV (Coefficient of Variation): SD/ Mean or DV

 CV percentage: SD/DV X100

 SD (Standard Deviation)

 SDI (Standard Deviation Index) = your result – DV/ SD of mean.

 U (uncertainty of the assigned value) derived from Robust SD for each participant lab

 Statically analysis on all method result. It displays the participants in each group theory mean before robust analysis the SD, CV & DV which is the mean afer robust analysis. Your method means, SDI & the RMSDI (running mean SDI).

 Parameter are generated by software & then checked and verified by NPHL NEQAS Team

Interpreting the SDI If the target SDI is O, which indicates there is no difference between the laboratory mean & the designated value( DV). A SDI of -1.7 indicates a negative bias of 1.7 SD from the Method mean (DV). SN SDI Range Interpretaion 1 Within -1.0 to + 1.0 Excellent 2 Between ± 1.0 to ± 2.0 Good 3 Between ±2.0 to ±3.0 Accept with caution warning signal 4 Beyond or morethan ± 3.0 Unacceptable performance. Action signal For details please contact NPHL NEQAS section

ABOUT TTIs NEQAS

NPHL initiated National External Quality Assessment Scheme (NEQAS)for blood transfusion service centers (BTSCs) in Nepal for Transfusion Transmitted Infections (TTIs)serology since year 2012 and your BTS center has been enrolled in NPHL’s TTIs serology NEQAS. sample within a panel is assigned a unique identifier. The participating BTSCs are required to test for TTIs markers for HIV, HBV, HCV and Syphilis on each sample.

Submit your findings in our TTIs Software that is available on our website: www.nphl.gov.np within one week of receiving the samples.

TARGET PARTICIPANTS: The participants represent all Nepal, including the district hospital, primary health center (PHC) blood transfusion service centre (BTSC) and other BTSC hospital based, government as well as private, small hospital, Private clinics and diagnostics centers BTSC.  Government: BTSC  Semi government: BTSC  Privet sectors: includes E, D, C, B, A categories BTSCs

NUMBER OF PARTICIPANTS /CRITERIA FOR PARTICIPANTS FOR NEQAS PROGRAM - Should be registered in Nepal Government (copy of registration related document under the MOHP/ NPHL-NBBTS/ NRCS- CBTS) - Latest copy of tax clearance document of BTSC OR HOSPITAL - Application letter with detail lab information. - Till 2077/10/05 BS 114 BTSC CENTER ARE IN NEPAL FREQUENCY / TIMES OF YEAR - It is conducted 2 times (2 lots) in a year - Program conducted in Shrawan- Bhadra & Baishak - Ashar. - Those who wish to enroll their laboratories during the cycle can do by applying the online registration participation.

THE PARAMETER INCUDES IN SCHEME:  HIV 1 & 2 Ab  Anti HCV antibody  HBsAg  Syphilis In one lot 4 SAMPLE AS A, B , C, D ( each sample should be check for HIV, HCV, HBsAg, syphilis) Note: example of sample labelled  NTQ 1-2077-A  NTQ 1-2077-B  NTQ-12077-C  NTQ-12077-D

To submit the results of TTIs NEQAS in the software please follow the procedure as given below:

1. Go to our www.nphl.gov.np website and click the button "BTSC Login" at the left top corner of the website.

2. Login with username and password that was provided by NPHL.

3. Click on the NEQAS For TTIs at the left corner of the page in the dashboard

4. Click on the create button and proceed

5. Feedback will be provided in your account after reviewing the reports by NBBTS.

REPORT ANALYSIS A score of 1 point is allocated for each of the four TTIs (HIV, HBV, HCV and Syphilis) screened, thus making a total of 4 points for every sample.  For each sample tested, a full score of 4 points will be allocated on correctly reporting for all 4 TTIs markers tested.  A score of zero point will be given for any incorrectly reported TTIs marker.  A score of zero is also given in case there is no answer or in case of non-participation (NP). One batch consists of 4 samples, hence total points for each batch would be 4 markers x 4 samples= 16. All participant should be submitting result via online software.

The scores obtained by participating BTSCs will be summed up and percentage scored will be calculated to evaluate the performance as below:  Scoring 100% in NEQAS - Excellent performance  Score between 90-100%-Need to be improve performance (Action required to troubleshoot the underlying problem)  Score below 90%- Unacceptable performance (Urgent action needed to review the technical competency of the BTSC and upgrade the quality of performance)